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Cochrane Database of Systematic Reviews Surgical hand antisepsis to reduce surgical site infection (Review) Tanner J, Dumville JC, Norman G, Fortnam M Tanner J, Dumville JC, Norman G, Fortnam M.
Surgical hand antisepsis to reduce surgical site infection.
Cochrane Database of Systematic Reviews2016, Issue 1. Art. No.: CD004288.
DOI: 10.1002/14651858.CD004288.pub3.
www.cochranelibrary.com Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by Jo hn Wiley & Sons, Ltd. T A B L E O F C O N T E N T S1 HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 21 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23 AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32 CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
75 DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 basic hand hygiene versus alcohol rub, Outcome 1 SSI. . . . . . . . . . . . . 79 Analysis 2.1. Comparison 2 chlorhexidine versus iodine, Out come 1 CFUs. . . . . . . . . . . . . . . 80 Analysis 3.1. Comparison 3 chlorhexidine versus iodine plus triclosan, Outcome 1 CFUs. . . . . . . . . . . 81 Analysis 4.1. Comparison 4 alcohol rub versus other alcohol ru b, Outcome 1 CFUs. . . . . . . . . . . . 81 Analysis 5.1. Comparison 5 scrub versus alcohol-only rub, Outco me 1 SSI. . . . . . . . . . . . . . . . 82 Analysis 6.1. Comparison 6 scrub versus alcohol rub, Outcome 1 S SI. . . . . . . . . . . . . . . . . 82 Analysis 7.1. Comparison 7 scrub (chlorhexidine) versus alcoho l rub + additional ingredient, Outcome 1 CFUs. . . 83 Analysis 8.1. Comparison 8 scrub (povidone iodine) versus alco hol rub + additional ingredient, Outcome 1 CFUs. . 84 Analysis 9.1. Comparison 9 scrub (chlorhexidine) versus rub + a dditional ingredient, Outcome 1 CFUs. . . . . . 84 Analysis 10.1. Comparison 10 scrub (chlorhexidine) versus alco hol rub + additional ingredient, Outcome 1 CFUs. . 85 Analysis 11.1. Comparison 11 duration - Kappstein (5 minutes versus 3 minutes), Outcome 1 CFUs immediately after antisepsis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Analysis 12.1. Comparison 12 duration - 5 + 3 min versus 3 + 0.5 min with chlorhexidine), Outcome 1 CFUs. . . 86 Analysis 13.1. Comparison 13 duration - 5 + 3 min versus 3 + 0.5 minutes with iodine), Outcome 1 CFUs. . . . 86 Analysis 14.1. Comparison 14 duration - 5 + 3.5 min versus 3 + 2 .5 min chlorhexidine), Outcome 1 CFUs. . . . 87 Analysis 15.1. Comparison 15 scrub versus scrub plus brush, Ou tcome 1 CFUS. . . . . . . . . . . . . . 88 Analysis 16.1. Comparison 16 scrub versus scrub plus nail pick, Outcome 1 CFUs. . . . . . . . . . . . . 88 Analysis 17.1. Comparison 17 scrub plus brush versus scrub plu s nail pick, Outcome 1 CFUs. . . . . . . . . 89 89 ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
92 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
98 FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
99 WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
99 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
100 CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
100 DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
101 SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
101 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
101 INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. [Intervention Review] Surgical hand antisepsis to reduce surgical site infection Judith Tanner1 , Jo C Dumville 2 , Gill Norman 2 , Mathew Fortnam 3 1 School of Health Sciences, University of Nottingham, Nottingh am, UK.2 School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK. 3 Cochrane Wounds Group, University of York, York, UK Contact address: Judith Tanner, School of Health Sciences, Univ ersity of Nottingham, Queens Medical Centre, Nottingham, NG 7 2HA, UK. [email protected] .
Editorial group: Cochrane Wounds Group.
Publication status and date: New search for studies and content updated (no change to conclusion s), published in Issue 1, 2016.
Review content assessed as up-to-date: 10 June 2015.
Citation: Tanner J, Dumville JC, Norman G, Fortnam M. Surgical hand anti sepsis to reduce surgical site infection.Cochrane Database of Systematic Reviews 2016, Issue 1. Art. No.: CD004288. DOI: 10.1002/14651858.C D004288.pub3.
Copyright © 2016 The Cochrane Collaboration. Published by Jo hn Wiley & Sons, Ltd.
A B S T R A C T Background Medical professionals routinely carry out surgical hand antis epsis before undertaking invasive procedures to destroy transient micro- organisms and inhibit the growth of resident micro-organisms . Antisepsis may reduce the risk of surgical site infections (SSI s) in patients.
Objectives To assess the effects of surgical hand antisepsis on preventin g surgical site infections (SSIs) in patients treated in any setting. The secondary objective is to determine the effects of surgical hand antisepsis on the numbers of colony-forming units (CFUs) of bact eria on the hands of the surgical team.
Search methods In June 2015 for this update, we searched: The Cochrane Wounds G roup Specialized Register; The Cochrane Central Register of Controlled Trials (CENTRAL) ( The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations) and EBSCO CINAHL. There were no restrictions with respect to language, date of publication or study setting.
Selection criteria Randomised controlled trials comparing surgical hand antisep sis of varying duration, methods and antiseptic solutions.
Data collection and analysis Three authors independently assessed studies for inclusion and trial quality and extracted data.
Main results Fourteen trials were included in the updated review. Four tri als reported the primary outcome, rates of SSIs, while 10 tria ls reported number of CFUs but not SSI rates. In general studies were smal l, and some did not present data or analyses that could be easily interpreted or related to clinical outcomes. These factors redu ced the quality of the evidence.
SSIs 1 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. One study randomised 3317 participants to basic hand hygiene(soap and water) versus an alcohol rub plus additional hydrogen peroxide. There was no clear evidence of a difference in the risk of SSI (risk ratio (RR) 0.97, 95% CI 0.77 to 1.23, moderate quali ty evidence downgraded for imprecision).
One study (500 participants) compared alcohol-only rub versus an aqueous scrub and found no clear evidence of a difference in the risk of SSI (RR 0.56, 95% CI 0.23 to 1.34, very low quality evide nce downgraded for imprecision and risk of bias).
One study (4387 participants) compared alcohol rubs with additi onal active ingredients versus aqueous scrubs and found no clear evidence of a difference in SSI (RR 1.02, 95% CI 0.70 to 1.48, low q uality evidence downgraded for imprecision and risk of bias).
One study (100 participants) compared an alcohol rub with an addi tional ingredient versus an aqueous scrub with a brush and found no evidence of a difference in SSI (RR 0.50, 95% CI 0.05 to 5.34, lo w quality evidence downgraded for imprecision).
CFUs The review presents results for a number of comparisons; key ndings include the following.
Four studies compared different aqueous scrubs in reducing CFU s on hands.Three studies found chlorhexidine gluconate scrubsresulted in fewer CFUs than povidone iodine scrubs immediately after s crubbing, 2 hours after the initial scrub and 2 hours after subsequent scrubbing. All evidence was low or very low quality, with downg rading typically for imprecision and indirectness of outcome. One trial comparing a chlorhexidine gluconate scrub versus a povidone iod ine plus triclosan scrub found no clear evidence of a difference-th is was very low quality evidence (downgraded for risk of bias, imp recision and indirectness of outcome).
Four studies compared aqueous scrubs versus alcohol rubs contai ning additional active ingredients and reported CFUs. In three comparisons there was evidence of fewer CFUs after using alcoho l rubs with additional active ingredients (moderate or very low quality evidence downgraded for imprecision and indirectness of outcom e). Evidence from one study suggested that an aqueous scrub was m ore effective in reducing CFUs than an alcohol rub containing additi onal ingredients, but this was very low quality evidence downgraded for imprecision and indirectness of outcome.
Evidence for the effectiveness of different scrub durations va ried. Four studies compared the effect of different durations of scrubs and rubs on the number of CFUs on hands. There was evidence that a 3 m inute scrub reduced the number of CFUs compared with a 2 minute scrub (very low quality evidence downgraded for imprecis ion and indirectness of outcome). Data on other comparisons were not consistent, and interpretation was dif cult. All further evidence was low or very low quality (typically downgraded for i mprecision and indirectness).
One study compared the effectiveness of using nail brushes and nail picks under running water prior to a chlorhexidine scrub on the number of CFUs on hands. It was unclear whether there was a diff erence in the effectiveness of these different techniques in terms of the number of CFUs remaining on hands (very low quality eviden ce downgraded due to imprecision and indirectness).
Authors’ conclusions There is no rm evidence that one type of hand antisepsis is bet ter than another in reducing SSIs. Chlorhexidine gluconate scrubs may reduce the number of CFUs on hands compared with povidone io dine scrubs; however, the clinical relevance of this surrogate outcome is unclear. Alcohol rubs with additional antiseptic in gredients may reduce CFUs compared with aqueous scrubs. With re gard to duration of hand antisepsis, a 3 minute initial scrub reduce d CFUs on the hand compared with a 2 minute scrub, but this was ver y low quality evidence, and ndings about a longer initial scrub and subsequent scrub durations are not consistent. It is unclear whether nail picks and brushes have a differential impact on the number of CFUs remaining on the hand. Generally, almost all evidenceavailable to inform decisions about hand antisepsis approaches that wer e explored here were informed by low or very low quality evide nce.
P L A I N L A N G U A G E S U M M A R Y Surgical hand antisepsis to reduce surgical site infection What are surgical site infections and who is at risk?
The inadvertent transfer of micro-organisms such as bacteria to a patient’s wound site during surgery can result in a wound infection that is commonly called a surgical site infection (SSI). SSIs are on e of the most common forms of health care-associated infections fo r surgical patients. Around 1 in 20 surgical patients develop an SSI in hospital, and this proportion rises when people go hom e. SSIs 2 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. result in delayed wound healing, increased hospital stays, increased use of antibiotics, unnecessary pain and, in extreme ca ses, the death of the patient, so their prevention is a key aim for health ser vices.
Why use hand antisepsis prior to surgery?
There are many different points in the care pathway where prev ention of SSIs can take place. This includes antiseptic cleansing of the hands for those who are operating on the patient. Surgical han d antisepsis is the focus of this review. The two most common for ms of hand antisepsis involve aqueous scrubs and alcohol rubs. Aque ous scrubs are water-based solutions containing antiseptic ingredients such as chlorhexidine gluconate or povidone iodine. Scrubbing i nvolves wetting the hands and forearms with water, systematically applying an aqueous scrub solution using either hands or spon ges, rinsing under running water and then repeating this process. Alcohol solutions containing additional active ingredients are used to perform an ’alcohol rub’. Surgical teams systematically app ly the alcohol rub solutions to their hands and allow it to evaporate. Alcoho l is effective against a wide range of bacteria and other micro-or ganisms.
Following hand antisepsis, operating staff then put on glov es, which provide an important barrier between operating sta ff and the patient; however, because gloves can become perforated during surgery, it is necessary to have hands as germ-free as possible.
What we found In June 2015 we searched for as many relevant studies that had a robust design (randomised controlled trials) as we could nd and compared different types of hand antisepsis before surgery. We included 14 studies that compared a range of methods for perf orming surgical hand antisepsis. The two measures used to assess the effectiveness of treatments were the number of cases of SSIs in patients (presented in four included studies) and the number of viable b acteria or fungal cells (known as colony-forming units, or CFUs) o n the hand of the person operating before surgery and after surger y (which is a way of counting the bacteria present on the skin surfa ce). It is not clear whether the method of hand antisepsis in uences the r isk of SSI, as most of the studies were too small and had aws. T here was some evidence that hand antisepsis with chlorhexidine may reduce the number of bacteria on the hands of health profession als compared with povidone iodine. Importantly, we do not know wh at the number of CFUs on the hands tells us about the likelihood of patients developing SSIs. There was also some evidence tha t alcohol rubs with additional antiseptic ingredients may reduce CFUs compared with aqueous scrubs.
Up-to-date June 2015 B A C K G R O U N D The inadvertent transfer of micro-organisms to patients’ wou nd sites during surgery can result in postoperative surgical sit e infec- tions (SSIs). SSIs are one of the most common forms of healthcare- associated infections for surgical patients ( NICE 2008 ). Around 5% of surgical patients develop an SSI ( NICE 2008 ), though this incidence can double when surveillance includes active postdis- charge follow-up ( Leaper 2015 ). SSIs result in delayed wound heal- ing, increased hospital stays, increased use of antibiotics, u nneces- sary pain and, in extreme cases, the death of the patient ( Plowman 2000 ).
Micro-organisms that cause SSIs come from a variety of sources within the operating room, including the hands of the surgical team. Members of the surgical team wear sterile gloves to prev ent transferring bacteria from their hands to patients. However , gloves can become perforated during surgery, so it is necessary to have hands as germ-free as possible. This is achieved by conducting surgical hand antisepsis immediately before donning steril e glovesprior to commencing surgical or invasive procedures. While hand- washing removes transient micro-organisms, surgical hand ant i- sepsis goes a step further to inhibit the growth of resident m i- croorganisms, thereby minimising the risk of a patient devel oping an SSI ( WHO 2009 ).This is achieved using antiseptic agents that kill and inhibit bacteria, fungi, protozoa and bacterial spor es. An ideal antiseptic agent would be fast-acting, persistent (effe ctive for a number of hours), cumulative (repeated exposure inhibits bact e- rial growth for a number of days), have a broad spectrum of activ- ity and be safe to use.There are several individual component s of surgical hand antisepsis, including the pre-wash; the applicat ion technique; the use of sponges, brushes or nail picks; the choice o f antiseptic solution and the duration of the antisepsis.
De ning terms - scrub and rubs Several different terms are used when describing surgical han d an- tisepsis. Antisepsis with running water and an aqueous solu tion 3 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. is referred to as a surgical or a traditional scrub. Antisepsiswith an alcohol solution is referred to as an alcohol rub or a water- less scrub. In this review, we understand surgical hand antise psis to encompass both methods of surgical antisepsis: scrubbing an d rubbing. The very rst antisepsis of the day is referred to as the initial antisepsis. Scrubs or rubs performed thereafter but on the same day are referred to as subsequent antisepses.
Surgical hand antisepsis - current practice The Association for Perioperative Practice (AfPP) recommends a pre-wash prior to the rst antisepsis of the day, when hands ar e washed with soap or an antimicrobial solution under running w a- ter ( AfPP 2011 ). The function of the pre-wash is to remove dirt (organic material). AfPP 2011 then recommends cleaning nails using a pick under running water. Clinicians can then perform an - tisepsis using either an antimicrobial solution with runnin g water, referred to as a traditional scrub, or an alcoholic rub without water. AfPP 2011 suggests alcohol rubs are more effective in reducing bacteria on the skin but should not be used if there is visible d irt present. The AfPP does not cite any speci c antimicrobial solut ion as being the most effective, but, like many other organisatio ns, rec- ommends that the solution chosen meets the ideal properties f or an antimicrobial solution ( ACORN 2012 ;AORN 2010 ;WHO 2009 ). These properties are identi ed by the Centers for Disease Control and Prevention (CDC) as the solution being:
fast-acting; persistent (effective for a number of hours); cumulative (repeated exposure inhibits bacterial growth for a number of days); having a broad spectrum of activity; and safe to use ( CDC 2002 ). AfPP 2011 recommends a duration of 2 to 5 minutes (depending on manufacturers instructions) for a traditional scrub, but do es not provide details on the recommended duration of an alcoholi c rub. There is some discrepancy regarding aspects of hand antise psis between different organisations. For example, the World He alth Organization (WHO) and the Australian College of Operating Room Nurses (ACORN) only recommend a pre-wash if hands are visibly dirty ( ACORN 2012 ;WHO 2009 ), and ACORN 2012 recommends that the rst scrub of the day last 5 minutes while subsequent scrubs last 3 minutes. Nail brushes no longer appe ar to be recommended as these can damage skin ( ACORN 2012 ;AfPP 2011 ;AORN 2010 ;WHO 2009 ).
Guidelines for surgical antisepsis also cover topics such as rin gs, arti cial nails and nail polish ( AORN 2010 ;ACORN 2012 ;AfPP 2011 ;HIS 2001 ;Mangram 1999 ). The impact of these factors on SSI is the focus of another Cochrane review ( Arrowsmith 2014 ).
There are concerns that hand antisepsis causes skin damage to staff hands and that some products are more abrasive than othe rs ( Larson 1986b ). This topic is outside the remit of this review. Surgical hand antisepsis solutions Solutions for hand antisepsis are either aqueous (water) bas ed or alcohol based.
Aqueous scrubs Aqueous scrubs are water based solutions containing active in- gredients that are used during traditional handscrubs. The m ost common solutions contain chlorhexidine gluconate or povidone iodine (see below). Scrubbing involves wetting the hands and fo re- arms with water, systematically applying an aqueous scrub sol u- tion using either hands or sponges, rinsing under running wa ter and then repeating the process.
Alcohol rubs Alcohol-based solutions are used to perform an ’alcohol rub’.
Health professionals apply the solution to dry hands and the n rub them together systematically before allowing the soluti on to evaporate. Alcohol rubs do not require water for their applica tion.
Some alcohol rub solutions contain additional active antisept ic agents.
Antiseptic agents Alcohol Alcohols have little or no residual effect, and the concentratio n rather than the type of alcohol is thought to be most important in determining its effectiveness ( Larson 1995 ). Alcohol rubs are usually available in preparations of 60% to 90% strength and are effective against a wide range of gram-positive and gram nega- tive bacteria, mycobacterium tuberculosis, and many fungi and viruses. The three main alcohols used are ethanol, isopropan ol and n-propanol, and some rubs may contain a mixture of these.
Compared with other common antiseptic products, alcohol is as- sociated with the most rapid and greatest reduction in microbia l counts ( Lowbury 1974a ), but it does not remove surface dirt as it does not contain surfactants or have a foaming action ( Hobson 1998 ). Alcohol-based solutions usually (but not always) contain additional active ingredients to combine the rapid bacteriocid al effect of alcohol with more persistent chemical activity.
Iodine and iodophors Iodine has mostly been replaced by iodophors, as iodine often causes irritation and discolouring of skin. Iodophors are comp osed of elemental iodine, iodide or triiodide, and a polymer carri er of high molecular weight ( WHO 2009 ). Combining iodine with var- ious polymers increases the solubility of iodine, promotes s ustained release of iodine and reduces skin irritation. Iodophors are effective 4 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. against a wide range of gram-positive and gram negative bacte- ria, mycobacterium tuberculosis, fungi and viruses ( Joress 1962 ).
Iodophors contain iodine with a carrier such as polyvinylpyrro li- done (PVP). PVP, also known as povidone, is a polymer that detox - i es and prolongs the activities of drugs. PVP prolongs the act ivity of iodine by releasing it slowly. A combination of PVP and iodi ne, known as povidone iodine (PI), is less irritating than earlier solu- tions of iodine tincture ( Joress 1962 ). Iodophors rapidly reduce transient and colonising bacteria but have little or no residu al ef- fect ( Larson 1990 ).
Chlorhexidine Chlorhexidine is a biguanide. It is effective against a wide r ange of gram-positive and gram-negative bacteria, lipophilic viruse s and yeasts ( Hibbard 2002a ). It is not sporicidal. Although its imme- diate antimicrobial activity is slower than that of alcohols, i t is more persistent because it binds to the outermost layer of ski n, the stratum corneum ( Larson 1990 ). Over time, repeated exposure can lead to a cumulative effect where both transient and residen t organisms are reduced ( Larson 1990 ). Chlorhexidine gluconate is effective in the presence of blood and other protein-rich biolog ical materials ( Hibbard 2002a ).
Quaternary ammonium compounds Quaternary ammonium compounds (QACs) are composed of a ni- trogen atom linked to four alkyl groups. Alkyl benzalkonium chlo- rides are the most widely used as antiseptics, though other com - pounds include benzethonium chloride, cetrimide and cetylpyri d- ium chloride. QACs are primarily bacteriostatic and fungista tic, although they are microbicidal against some organisms at high concentrations.They are more active against gram-positive bact e- ria than against gram-negative bacilli. QACs have relatively weak activity against mycobacteria and fungi and greater activity ag ainst lipophilic viruses. Their antimicrobial activity is adverse ly affected by the presence of organic material, and they are not compatibl e with anionic detergents. In 1994, the Food and Drug Administ ra- tion (FDA) Tentative Final Monograph (TFM) tentatively class i- ed benzalkonium chloride and benzethonium chloride as havin g insuf cient data to classify as safe and effective for use as an a nti- septic handwash ( WHO 2009 ).
Hexachlorophene Hexachlorophene is a halophenol compound. It is a slow-acting antiseptic that forms a lm over the skin ( Crowder 1967 ). The lm retains bacteriostatic properties and is effective again st gram- positive bacteria but is less effective with gram-negative bact eria and fungi ( Crowder 1967 ). A report of toxicity in neonates led to restricted usage ( Kimborough 1973 ), and today, hexachlorophene has mostly been replaced by triclosan. Triclosan Triclosan (2,4,4’-trichloro-2’-hydroxydiphenyl ether) has bee n in- corporated in detergents (0.4% to 1%) and alcohols (0.2% to 0.5%) used for hygienic and surgical hand antisepsis or preop er- ative skin disinfection. It inhibits staphylococci, coliforms, enter- obacteria and a wide range of gram-negative intestinal and ski n ora ( Bartzokas 1983 ). Most strains of pseudomonas are resistant, and triclosan has only fair activity against mycobacterium tube r- culosis and poor activity against fungi ( Faoagali 1995 ).
Chloroxylenol Chloroxylenol, also known as para-chloro-meta-xylenol (PCMX), is a halogen-substituted phenolic compound. It is not as quick- acting as chlorhexidine or iodophors, and its residual activit y is less pronounced than that observed with chlorhexidine glucona te ( McDonnell 1999 ). In 1994, the FDA TFM tentatively classi ed chloroxylenol as having insuf cient data to classify as safe an d effective ( WHO 2009 ).
O B J E C T I V E S To assess the effects of surgical hand antisepsis on preventin g sur- gical site infections (SSIs) in patients treated in any setting . The secondary objective is to determine the effects of surgical hand antisepsis on the number of bacteria colony-forming units (CFUs ) present on the hands of the surgical team.
M E T H O D S Criteria for considering studies for this review Types of studies All published and unpublished randomised controlled trials (RCTs) of surgical hand antiseptic techniques were included. Co n- trolled clinical trials were to be considered in the absence of RC Ts.
Two possible units of randomisation were considered: the scru b team or individual members of the scrub team.
Types of participants All members of the scrub team or personnel working within the operating theatre or day case setting. The SSI outcome is measu red in participants who have undergone surgery. 5 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Types of interventions This review included comparisons of the following with each other and/or placebo and/or no antisepsis: Surgical hand antisepsis; Aqueous scrub solutions.
Alcohol rubs.
Alcohol rubs containing additional active ingredients.
Surgical hand antisepsis of different durations.
Surgical hand antisepsis using different equipment (e.g.
brush, sponge, nail pick).
Types of outcome measures Primary outcomes Occurrence of postoperative SSI, as de ned by the CDC ( Mangram 1999 ) or the study authors. We did not differentiate between super cial and deep-incisional infection.
Secondary outcomes Number of bacterial CFUs found on the hands of the surgical team.
Search methods for identi cation of studies Electronic searches We describe the search methods of the original version and rst update of this review in Appendix 1 .
For this rst update we searched:
The Cochrane Wounds Group Specialized Register (searched 10 June 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 6); Ovid MEDLINE (1946 to 9 June 2015); Ovid MEDLINE - In-Process & Other Non-Indexed Citations (9 June 2015); Ovid EMBASE (1974 to 9 June 2015); EBSCO CINAHL (1982 to 10 June 2015).
The following search strategy was used in the Cochrane Central Register of Controlled Trials (CENTRAL):
#1 MeSH descriptor Surgical Wound Infection explode all trees #2 MeSH descriptor Surgical Wound Dehiscence explode all trees #3 surg* NEAR/5 infect*:ti,ab,kw #4 surg* NEAR/5 wound*:ti,ab,kw #5 surg* NEAR/5 site*:ti,ab,kw #6 surg* NEAR/5 incision*:ti,ab,kw #7 surg* NEAR/5 dehiscen*:ti,ab,kw #8 ((post-operative or postoperative) NEAR/5 (wound NEXT in- fection*)):ti,ab,kw #9 MeSH descriptor Preoperative Care explode all trees #10 MeSH descriptor Perioperative Care explode all trees #11 ((preoperative or pre-operative) NEXT care):ti,ab,kw #12 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11) #13 MeSH descriptor Skin explode all trees #14 MeSH descriptor Antisepsis explode all trees #15 (#13 AND #14) #16 antisepsis:ti,ab,kw #17 MeSH descriptor Anti-Infective Agents, Local explode all tr ees #18 MeSH descriptor Soaps explode all trees #19 MeSH descriptor Povidone-Iodine explode all trees #20 MeSH descriptor Iodophors explode all trees #21 MeSH descriptor Chlorhexidine explode all trees #22 MeSH descriptor Alcohols explode all trees #23 MeSH descriptor Detergents explode all trees #24 (iodophor* or povidone-iodine or betadine or chlorhexidin e or triclosan or hexachlorophene or benzalkonium or alcohol or alcohols or antiseptic* or soap* or detergent*):ti,ab,kw #25 MeSH descriptor Disinfection explode all trees #26 MeSH descriptor Disinfectants explode all trees #27 (#25 OR #26) #28 (#13 AND #27) #29 (skin NEAR/5 disinfect*):ti,ab,kw #30 (#15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #28 OR #29) #31 MeSH descriptor Handwashing explode all trees #32 MeSH descriptor Hand explode all trees #33 (“hand” or “hands” or handwash* or (hand NEXT wash*) or (surgical NEXT scrub*)):ti,ab,kw #34 (#31 OR #32 OR #33) #35 (#12 AND #30 AND #34) The search strategies for Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL are available in Appendix 2 ,Appendix 3 and Appendix 4 , respectively. We combined the Ovid MEDLINE search with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity- an d pre- cision-maximising version (2008 revision) ( Lefebvre 2011 ). We combined the EMBASE search with the Ovid EMBASE lter terms developed by the UK Cochrane Centre ( Lefebvre 2011 ). We combined the CINAHL search with the trial lters developed by the Scottish Intercollegiate Guidelines Network (SIGN) ( SIGN 2011 ). There were no restrictions with respect to language, date of publication or study setting.
Searching other resources We handsearched the bibliographies of all retrieved and rele vant publications identi ed by these strategies for further stud ies. 6 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Data collection and analysis Selection of studies For the original review, three authors independently assessed the ti- tles and abstracts of potentially relevant studies identi e d through the search strategy, retrieving the full text of all studies t hat poten- tially met the criteria. If it was unclear from the title or abst ract whether a study met the criteria or there was a disagreement ov er the eligibility, we retrieved the full text of the study. The three authors then decided independently whether or not to include t he studies. There were no disagreements among authors regardi ng which studies to include.
For the update, two authors independently assessed all titl es and abstracts using the same methods, seeking assistance from tra nsla- tors where necessary. Again, there were no disagreements amo ng authors about which studies to include.
Data extraction and management We piloted a standardised data extraction form, and two autho rs independently used the nalised version to extract the follo wing data from studies:
Trial data extracted Duration of surgical antisepsis Antiseptic solution used Equipment used (e.g. brush, sponge, nail pick) Role of the person carrying out the hand antisepsis, for example, scrub nurse or surgeon Scrub history of the person scrubbing, for example, initial or subsequent scrub Surgical specialty, for example, orthopaedics, ophthalmics, urology, etc. Type of surgical procedure: elective or emergency Duration of surgical procedure Surgical glove material Size of groups Method of SSI detection Duration of follow-up Trial outcomes Number of SSIs Number of CFUs (bacteria) on hands of surgical team Assessment of risk of bias in included studies Two review authors independently assessed the included stud ies using the Cochrane tool for assessing risk of bias ( Higgins 2011 ). This tool addresses six speci c domains: sequence generation , al- location concealment, blinding, incomplete data, selective out - come reporting and other issues ( Appendix 5 ). In this review we recorded issues with unit of analysis, for example where a clus ter trial had been undertaken but analysed at the individual lev el in the study report. We assessed blinding of outcome assessment and completeness of outcome data for each of the review outcomes separately. For this review, we anticipated that blinding of par- ticipants (surgical staff ) may not be possible. For this reason the assessment of the risk of detection bias focused on whether tri als reported blinded outcome assessment (because wound infection can be a subjective outcome, it can be at high risk of measurement bias when outcome assessment is not blinded).
We presented our assessment of risk of bias using two ’Risk of bias’ summary gures; one which is a summary of bias for each item across all studies, and a second which shows a cross-tabulation of each trial by all of the risk of bias items. We summarised a stud y’s risk of selection bias, detection bias, attrition bias, repor ting bias and other bias.
Data synthesis Data were entered into Review Manager software ( RevMan 2014 ).
Continuous outcomes (i.e. CFUs) were reported as mean differ- ences (MDs) with 95% con dence intervals (CI). Dichotomous outcomes (i.e. SSIs) were presented as risks ratio (RR) with 95% CI. We reported ndings narratively and considered pooling o f data after exploring clinical and statistical heterogeneity. We exam- ined clinical heterogeneity by looking at the type of interven tion, the participant population and the type of surgery. For asses sment of statistical and related heterogeneity we used I 2 values ( Higgins 2003 ). I 2 examines the percentage of total variation across RCTs that is due to heterogeneity rather than chance ( Higgins 2003 ).
Very broadly, we considered that I 2 values of 25%, or less, may mean a low level of heterogeneity Higgins 2003 , and values of more than 75%, or more, indicate very high heterogeneity.
Handling of data where the appropriateness of the analysis reported in the paper was unclear.
Where the trial had a cross-over design or was cluster-randomised but the analysis did not appear to take this into account, we re- ported the available raw data (e.g. mean values) as well as the effect estimate calculated in the paper and discussed the likely effect of an incorrect analysis on the effect estimate.
’Summary of ndings’ tables In the update, in line with current Cochrane methods, we planne d to present the main results of the review in ’Summary of ndin gs’ tables where we had pooled data. These tables present key inf or- mation concerning the quality of the evidence, the magnitude of the effects of the interventions examined and the sum of avail able 7 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. data for the main outcomes ( Schünemann 2011a ). The ’Summary of ndings’ tables also include an overall grading of the evid ence related to each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation ) approach. The GRADE approach de nes the quality of a body of evidence as the extent to which one can be con dent that an esti- mate of effect or association is close to the true quantity of spe ci c interest. The quality of a body of evidence involves considera tion of within-trial risk of bias (methodological quality), directne ss of evidence, heterogeneity, precision of effect estimates and ri sk of publication bias ( Schünemann 2011b ). We planned to present the following outcomes in the ’Summary of ndings’ tables for each comparison. SSI events Number of CFUs Where we did not pool data, we decided to conduct the GRADE assessment for each comparison and present this narratively w ithin the Results section without the presentation of separate ’Su mmary of ndings’ tables.
R E S U L T S Description of studies Also see Characteristics of included studies and Characteristics of excluded studies .
Results of the search The search for this update took place in June 2015 and yielded 27 4 abstracts. We obtained 18 of these as full-text records for furt her assessment, subsequently excluding 14 (see Excluded studies ) and including four ( Al-Naami 2009 ;Nthumba 2010 ;Tanner 2009 ; Vergara-Fernandez 2010 ). The addition of these four new studies to the 10 studies in the previous version of the review brough t the total number of studies included in this update to 14.
Over the life of the review, we have made attempts to contact sev en authors to obtain further information ( Gupta 2007 ,Hajipour 2006 ;Herruzo 2000 ;Kappstein 1993 ;Pereira 1997 ;Pietsch 2001 ; Sensoz 2003 ). Five authors responded ( Hajipour 2006 ;Herruzo 2000 ;Kappstein 1993 ;Pereira 1997 ;Sensoz 2003 ). We included Hajipour 2006 ,Herruzo 2000 ,Kappstein 1993 ,Pereira 1997 and Pietsch 2001 in the review. We also included Gupta 2007 , al- though we have not carried out any independent analyses on the ir ndings. The update identi ed one study (from a bibliographi c search) that is awaiting assessment pending further informa tion ( Chen 2012 ). Included studies We present an overview of included studies and comparisons in Table 1 .
We identi ed and included 14 eligible trials in this review. F our trials reported the primary outcome, namely SSI ( Al-Naami 2009 ; Nthumba 2010 ;Parienti 2002 ;Vergara-Fernandez 2010 ). The remaining 10 trials reported the number of CFUs (on the hands o f the surgical team), which is a surrogate outcome that is thought t o give an impression of the likelihood of infection. All 14 tria ls took place in operating departments, with 8 studies involving sur gery and 6 testing interventions in surgical staff but without sur gery taking place. Of the included studies, four compared different durations of scrubs or rubs ( Kappstein 1993 ;Pereira 1990 ;Pereira 1997 ;Wheelock 1997 ).
Some of the included studies had complicated designs: Parienti 2002 was an equivalence, cluster, cross-over trial where the unit of randomisation was the surgical service. Each surgical service car - ried out one intervention for one month and then switched to th e alternative intervention the following month. Nthumba 2010 also used a cluster, cross-over design, whereby operating theatres were allocated to an intervention with cross-over every two months.
We also considered Hajipour 2006 to be a cluster trial, as it ran- domised four surgeons to different antisepsis methods which they used prior to surgery on multiple participants. Seven other s tud- ies ( Gupta 2007 ,Herruzo 2000 ,Kappstein 1993 ,Pereira 1990 ; Pereira 1997 ;Pietsch 2001 ;Wheelock 1997 ) were also cross-over trials.
De nition of scrub procedure Six trials gave detailed protocols for their antisepsis techn iques ( Furukawa 2005 ;Parienti 2002 ;Pereira 1990 ;Pereira 1997 ;Tanner 2009 ;Wheelock 1997 ). Authors from eight trials reported using a brush or sponge ( Gupta 2007 ;Furukawa 2005 ;Herruzo 2000 ; Parienti 2002 ;Pereira 1990 ;Pereira 1997 ;Vergara-Fernandez 2010 ), while Tanner 2009 compared a nail brush and nail pick. Parienti 2002 and Wheelock 1997 stated that antisepsis proto- cols met with national guidelines. Seven of the trials employ ed a ’supervisor’ to observe compliance with the antisepsis prot ocol ( Furukawa 2005 ;Nthumba 2010 ;Parienti 2002 ;Pereira 1990 ; Pereira 1997 ;Tanner 2009 ;Wheelock 1997 ). Three trials pre- sented minimal details of the antisepsis protocol ( Gupta 2007 ; Hajipour 2006 ;Nthumba 2010 ), and the remaining ve trials did not comment on antisepsis techniques ( Al-Naami 2009 ;Herruzo 2000 ;Kappstein 1993 ;Pietsch 2001 ;Vergara-Fernandez 2010 ).
Excluded studies See Characteristics of excluded studies Risk of bias in included studies 8 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. We summarise our ’Risk of bias’ assessment in Figure 1 ,Figure 2 and in the ’Risk of bias’ assessment tables. Overall, most studies were at unclear risk or high risk of bias for one of the followin g:
selection bias, detection bias and attrition bias. Only two st udies were at low risk of bias for all these ( Nthumba 2010 ;Tanner 2009 ).
Figure 1. Risk of bias graph: review authors’ judgements abo ut each risk of bias item presented as percentages across all included studies. 9 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Figure 2. Risk of bias summary: review authors’ judgements about each risk of bias item for each included study. 10 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. We considered four studies to be at low risk of detection bias, as they blinded outcome assessors ( Al-Naami 2009 ;Nthumba 2010 ; Hajipour 2006 ;Tanner 2009 ). We considered two studies to be at high risk of detection bias ( Parienti 2002 ;Wheelock 1997 ).
We also judged two studies to be at high risk of attrition bias . Pereira 1997 reported that 9/32 randomised members of staff failed to complete with no reasons given for withdrawal. Al-Naami 2009 excluded 100 of 600 patients from the analysis for reasons such as their condition was revised on subsequent histopathol og- ical examination, they had incomplete forms, or they “failed f ol- low-up”.
We judged several studies to be at unclear risk of other bias du e to uncertainty as to whether a cluster-randomised or cross-over design had been taken into account in the analysis. Parienti 2002 and Hajipour 2006 were at unclear risk of other bias as a cluster design was detected but it did not seem that clustering had been taken into account in the analyses. Herruzo 2000 ,Kappstein 1993 , Pereira 1990 ,Pereira 1997 ;Wheelock 1997 were at unclear risk because it appeared that the crossover designs had not been tak en into consideration in the analyses.
Effects of interventions We included 14 trials in this review. In total, the trials eval uated nine basic comparisons related to the type (i.e. scrub or rub, act ive ingredients), duration and tools used for surgical hand antis epsis.
Comparison 1 : basic hand hygiene versus alcohol rub containing additional active ingredients ( Nthumba 2010 ).
Comparison 2 : different aqueous scrub solutions:
chlorhexidine gluconate versus povidone iodine ( Furukawa 2005 ;Herruzo 2000 ;Pereira 1990 ;Pereira 1997 ).
Comparison 3 : comparison of different alcohol rubs containing additional active ingredients ( Gupta 2007 ;Pereira 1997 ).
Comparison 4 : aqueous scrubs versus alcohol-only rubs ( Al-Naami 2009 ).
Comparison 5 : aqueous scrubs versus alcohol rubs containing additional active ingredients ( Gupta 2007 ;Hajipour 2006 ;Herruzo 2000 ;Parienti 2002 ;Pietsch 2001 ; Vergara-Fernandez 2010 ).
Comparison 6 : duration of surgical antisepsis ( Kappstein 1993 ;Pereira 1990 ;Pereira 1997 ;Wheelock 1997 ).
Comparison 7 : surgical hand antisepsis using a nail pick versus surgical hand antisepsis not using a nail pick ( Tanner 2009 ).
Comparison 8 : surgical hand antisepsis using a brush versus surgical hand antisepsis not using a brush ( Tanner 2009 ).
Comparison 9 : surgical hand antisepsis using a nail pick versus surgical hand antisepsis using a brush ( Tanner 2009 ). Comparison 1: basic hand hygiene versus alcohol rub containing additional active ingredients (1 study) Basic hand hygiene (soap and water) compar ed with 75% iso- propyl alcohol plus 0.125% hydrogen peroxide Nthumba 2010 compared soap and water with an alcohol rub which contained hydrogen peroxide as an additional active ingr e- dient. Surgeons in both groups scrubbed with soap and water fo r 4 to 5 minutes before the rst procedure of the day and subsequen tly if there was visible soiling. For subsequent procedures, sur geons were randomised in clusters based on operating theatre to soa p and water or 7 to 10 ml of a locally produced hand rub based on isopropyl alcohol with hydrogen peroxide, which they applied for 3 minutes and kept wet. The trial used a total of 10 clusters, ea ch de ned by six operating theatres, across ve two-month interv als, with cross-over after each two-month period. The trial included 3317 patients undergoing clean and clean-contaminated surgery and assessed SSI at 30 days using modi ed CDC de nitions. The re appeared to be a low risk of bias for all domains except the blin ding of participants and personnel, which would have been dif cult t o achieve. Trialists accounted for both the clustering and cross-ov er in the power calculation and in the analyses.
Outcomes Surgical site infection (SSI) Nthumba 2010 collected SSI data for 30 days after discharge.
There was no clear difference in the number of SSIs between groups. In total, 8% (128/1596) of participants developed SSI in the soap and water scrub group compared with 8.3% (127/1537) in the alcohol rub group (RR 0.97, 95% CI 0.77 to 1.23). This was based on a complete case analysis; data were unavailable fo r 5.5% (184/3317) of participants and were not imputed. Losses t o follow-up were comparable between the two arms, at 5.1% (86/ 1682) for soap and water scrub versus 6.0% (98/1635) for alcohol rub ( Analysis 1.1 ).
Moderate quality evidence, downgraded once for imprecisio n.
A GRADE assessment of moderate quality evidence means that further research is likely to have an important impact on our con dence in the estimate of effect and may change the estima te.
Number of colony forming units (CFUs) Not reported 11 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Comparison 1 Summary: Basic hand hygiene compared to alcohol rubs containing additional active ingredients It is not clear whether hand antisepsis with soap and water is more or less effective in preventing subsequent SSI than antiseps is with an alcohol rub containing hydrogen peroxide (moderate quality evidence).
Comparison 2: different aqueous scrub solutions:
chlorhexidine gluconate versus povidone iodine (4 trials) Four studies compared chlorhexidine gluconate versus povidon e iodine but used different regimens.
Pereira 1990 randomly assigned 34 participants (operating room nurses) to one of four groups. The four interventions (which we re used for 1 week) were 4% chlorhexidine gluconate (Hibiclens) or 7.5% povidone iodine (Betadine), using a 5 minute initial and 3 minute subsequent scrub; and 4% chlorhexidine gluconate (Hibi- clens) or 7.5% povidone iodine (Betadine) using a 3 minute init ial and 30 second subsequent scrub. Control of the order of interve n- tions was through a Latin square design. Investigators took hand bacterial samples immediately after the initial scrub, 2 hour s after the initial scrub and 2 hours after the subsequent scrub. Altho ugh the study had a cross-over design, it did not appear that this wa s taken into consideration in the analysis, thus 95% CIs may be overestimated. Furukawa 2005 compared 4% chlorhexidine gluconate (Hibis- crub) with 7.5% povidone iodine (Isodine) using a 3 minute scrub .
Twenty-two operating room nurses were randomised to one of the two intervention groups. Each nurse took part only once. Th e nurses did not take part in any actual surgery. Herruzo 2000 randomised 154 members of surgical teams and compared three intervention groups: relevant to this compari son was a 3 minute scrub of either aqueous chlorhexidine gluconate 4% or aqueous povidone iodine 7.5%. The study had a cross-over design, which appears to have been accounted for. The study also reports repeated measures which does not appear to have been accounted for in the analysis. Pereira 1997 compared 4% chlorhexidine gluconate (Hibiclens) with 5% povidone iodine plus 1% triclosan (Microshield PVP) using a 3 minute initial and 2.5 minute subsequent scrub. Twen ty- three operating room nurses were randomised to carry out each o f ve interventions for one week each. The order of interventio ns was controlled through a Latin square design. Participants di d not take part in any actual surgery. Investigators took hand bacte rial samples immediately after the rst antisepsis, 2 hours afte r the rst antisepsis and 2 hours after the subsequent antisepsis. Alt hough the study had a cross-over design, it did not appear that triali sts took this into consideration in the analysis, thus the 95% CI m ay be overestimated. Outcomes Surgical site infection Not reported Number of colony forming units (CFUs) Chlorhexidine gluconate compared with povidone iodine Pereira 1990 compared 4% chlorhexidine gluconate (Hibiclens) with 7.5% povidone iodine (Betadine) using a 5 minute initial and 3 minute subsequent scrub. There was some evidence that scrubbing with chlorhexidine might be more effective than with povidone iodine in reducing the number of CFUs on the hand immediately after scrubbing (MD 0.34, 95% CI 0.64 to 0.04; ), 2 hours after the initial scrub (MD 0.75, 95% CI 1.06 to 0.44) and 2 hours after the subsequent scrub (MD 1.10, 95% CI 1.42 to 0.78; Analysis 2.1 ).
Because the analysis did not account for the effects of paired dat a resulting from the cross-over design, the study may have overe s- timated the uncertainty of the effect estimate; the correct 95% CIs for the estimate may be narrower than those reported here .
However, the study also used a repeated measures design which the analysis did not account for; this could lead to an underesti ma- tion of the uncertainty. The interaction of these two factors ma kes the true con dence intervals unclear, so we have downgraded the evidence twice due to imprecision.
Very low quality evidence due to imprecision and indirectne ss of outcome. Downgraded twice for imprecision due to two ana- lytical issues which mean precision estimates may change up on correct analysis of data, and downgraded twice for indirect ness as CFU is a surrogate outcome and because the intervention was used in the absence of surgery being conducted. A GRADE assessment of very low quality evidence means any estimate o f effect is very uncertain. Pereira 1990 compared 4% chlorhexidine gluconate (Hibiclens) with 7.5% povidone iodine (Betadine) using a 3 minute initial and 30 second subsequent scrub. There was evidence that chlorhexi- dine may be more effective than povidone iodine in reducing the number of CFUs immediately post scrubbing (MD 0.17, 95% CI 0.28 to 0.06), 2 hours after the initial scrub (MD 0.41, 95% CI 0.72 to 0.10) and 2 hours after the subsequent scrub (MD 0.65, 95% CI 0.93 to 0.37 Analysis 2.1 ).
Very low quality evidence due to imprecision and indirectne ss of outcome (as above).
In Furukawa 2005 , there were fewer CFUs in the chlorhexidine gluconate group after scrubbing (MD 2.40, 95% CI 3.26 to 1.54; Analysis 2.1 ). 12 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Low quality evidence: downgraded twice for indirectness as CFU is a surrogate outcome and because the intervention was used in the absence of surgery being conducted.
In Herruzo 2000 , there was evidence that a 3 minute aqueous scrub using chlorhexidine gluconate was more effective in reduci ng CFUs on hands than a 3 minute aqueous scrub using povidone iodine, both immediately after antisepsis (MD 48.00, 95% CI 50.57 to 45.4) and at the end of a surgical procedure (MD 132.0, 95% CI 141.20 to 122.80; Analysis 2.1 ). Because the analysis did not account for the repeated measures, the stu dy may have underestimated uncertainty around the effect estima te:
the true con dence intervals for the estimate may be wider than those reported here.
Low quality evidence; downgraded once as precision estimat es may change upon correct analysis of data and downgraded once due to indirectness as CFU is a surrogate outcome.
We considered pooling the three studies (four comparisons)( Furukawa 2005 ;Herruzo 2000 ;Pereira 1990 ); however, in light of the high degree of statistical heterogeneity for each possi ble comparison (ranging from 100% to 56%) and the differences in interventions noted, we did not undertake this.
Chlorhexidine gluconate compared with povidone iodine plu s triclosan Pereira 1997 reported no evidence of a difference in CFUs imme- diately after the rst antisepsis (MD 0.38, 95% CI 0.84 to 0.08) ( Analysis 3.1 ) and 2 hours after the rst antisepsis (MD 0.38, 95% CI 0.90 to 0.14) (Analysis 3.2). The trial found a difference in favour of chlorhexidine 2 hours after the subseq uent antisepsis (MD 0.69, 95% CI 1.13 to 0.25) ( Analysis 3.1 ).
Because the analysis did not account for the effects of paired dat a resulting from the cross-over design or for the effect of using r e- peated measures, the true con dence intervals for the estimat e are uncertain.
Very low quality evidence downgraded once for risk of attrit ion bias; twice for imprecision and twice for indirectness - onc e for indirectness of outcome and once because the intervention w as used in the absence of surgery being conducted.
Comparison 2 Summary : Comparison of different aqueous scrub solutions - chlorhexidine gluconate compared with povidone iodine Data from four trials ( ve comparisons) of chlorhexidine-contai n- ing aqueous scrub solutions with povidone iodine containing s olu- tions (all having initial longer duration of use followed by s horter subsequent use) suggest that chlorhexidine containing agent s may reduce the numbers of CFU on the hands to a greater extent than povidone iodine containing solutions. However, overall thi s is low or very low quality evidence, and the number of CFUs is a surro- gate outcome for SSI. Some of the studies included appeared to have been incorrectly analysed and one was at high risk of attri tion bias. No trials reported SSI events so there is no evidence to l ink the number of CFUs to clinical outcomes.
Comparison 3: comparison of different alcohol rubs containing additional active ingredients (2 trials) Two trials compared alcohol rubs containing additional active i n- gredients ( Gupta 2007 ;Pereira 1997 ). Gupta 2007 compared three 2 ml aliquots of 1% chlorhexidine gluconate in 61% ethyl alcohol (Avagard) against a 3 minute ap- plication of zinc pyrithione in 70% ethyl alcohol (Triseptin). The 61% alcohol solution is a waterless product, and the 70% alco- hol solution is a water aided product which requires rinsing wi th water. Eighteen operating room staff used each product for ve consecutive days. Testing was carried out immediately before a nd after antisepsis on day one, and at the end of days two and ve. Pereira 1997 compared 0.5% chlorhexidine gluconate in iso- propanol compared with 0.5% chlorhexidine gluconate in ethanol. The alcohol rubs were used immediately after an aque ous scrub (with 4% chlorhexidine gluconate) and also as the subse- quent antiseptic agent. The active ingredient in both alcohol rubs was the same (i.e. 0.5% chlorhexidine gluconate), and both prepa - rations had 70% strength alcohol, the only difference being th e alcohol (isopropanol versus ethanol). Scrubs lasted for 2 minut es, and the initial and subsequent applications of alcohol rubs la sted for 30 seconds.
Outcomes Surgical site infection Not reported Number of colony forming units (CFUs) Pereira 1997 did not nd a difference in the number of CFUs be- tween the isopropanol- and ethanol-based rubs immediately a fter the rst antisepsis (MD 0.00, 95% CI 0.57 to 0.57), 2 hours after the rst antisepsis (MD 0.07, 95% CI -0.45 to 0.59) or 2 hours after the subsequent antisepsis (MD 0.11, 95% CI 0.49 to 0.71); see Analysis 4.1 . Differences between groups were con- sistently small and imprecise. As previously noted, the true con - dence intervals for the effect estimates is uncertain because of the issues with the analysis.
Very low quality evidence due to risk of bias of attrition bia s; imprecision and indirectness of outcome. Gupta 2007 did not present suf cient raw data in the trial report to allow us to conduct independent statistical analyses, so we h ave contacted the author for further information. In the interim, we present Gupta 2007 ’s own analysis. Although the trial used a cross- over design, we could not determine if this was accounted for in 13 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. the analysis. When the CFUs were compared over the duration of the study, Gupta 2007 found no statistically signi cant difference between the solutions (P = 0.21). It must be noted that this anal ysis has not been independently veri ed.
Very low quality evidence downgraded due to indirectness of aggregate data that has not be checked or veri ed by review authors; also downgraded due to indirectness of outcome and imprecision as no CIs available.
Comparison 3 Summary: Comparison of different alcohol rubs containing additional active ingredients.
The comparative effects of different alcohol rubs (each containin g additional active ingredients) on number of CFUs are unclear, as the existing evidence is very sparse and of very low quality.
Comparison 4: aqueous scrubs versus alcohol-only rubs (1 trial) Al-Naami 2009 compared a traditional 3 to 5 minute scrub with either chlorhexidine or povidone iodine versus 10 ml of a 62% ethyl alcohol handrub, which was allowed to dry. Surgeons in bo th groups scrubbed with the aqueous solution for the rst procedu re of the day. The study was described as an equivalence trial. Six hun- dred patients undergoing clean and clean-contaminated surgery were randomised to the two arms; investigators reported dat a for 500 patients. Reasons for participants being excluded from th e analysis included a revised assessment of their condition on s ubse- quent histopathological examination, incomplete forms or fa iled follow-up. More patients in the traditional scrub arm (24%, 72/ 300) were excluded from the analysis than in the alcohol rub arm (9%, 28/300).
Outcomes Surgical site infection (SSI) Al-Naami 2009 collected SSI data over 30 days from surgery. There was no clear evidence of a difference in number of SSIs, with 2.9% (8/272) of participants in the alcohol rub arm having an SSI compared with 5.2% (12/228) in the aqueous scrub group (RR 0.56, 95% CI 0.23 to 1.34) ( Analysis 5.1 ). This trial was considered to be at high risk of attrition bias.
Very low quality evidence; downgraded once due to risk of at- trition bias and twice for imprecision.
Number of colony forming units Not reported Comparison 4 Summary: Aqueous scrubs compared with alcohol only rubs It is unclear whether there is a difference in SSIs between aque ous handscrubs and alcohol-only rubs (very low quality evidence from one study).
Comparison 5: aqueous scrubs versus alcohol rubs containing additional active ingredients (6 trials) Six studies compared traditional scrubs with alcohol rubs conta in- ing additional active ingredients ( Gupta 2007 ;Hajipour 2006 ; Herruzo 2000 ;Parienti 2002 ;Pietsch 2001 ;Vergara-Fernandez 2010 ). The six trials used different antiseptic solutions, there fore it was not appropriate to perform a meta-analysis. Each trial i s considered separately. Parienti 2002 compared a 5 minute scrub using either 4% povi- done iodine (Betadine) or 4% chlorhexidine gluconate (Hibis- crub) versus a 5 minute handrub using 75% propanol-1, propanol - 2 with mecetronium ethylsulphate (Sterillium). Participants i n the aqueous scrub group could choose between chlorhexidine glu- conate or povidone iodine solutions. Participants in the hand rub- bing group carried out a single handwash for 1 minute with non- antiseptic soap at the start of each day. The entire scrub team i n each of six hospitals took part. The trial included 4387 consec- utive patients undergoing clean and clean-contaminated surger y and assessed SSI at 30 d using the CDC de nition. The study was an equivalence, cluster cross-over trial but did not appear to ha ve accounted for the clustering in the analysis. Vergara-Fernandez 2010 compared an aqueous scrub with 4% chlorhexidine gluconate (which involved the use of a brush and a sponge) versus a handrub using 61% ethyl alcohol plus 1% chlorhexidine gluconate. Mean duration of the aqueous scrub wa s 3.9 minutes (SD 1.07), and mean duration of the alcohol rub was 2.0 minutes (SD 0.47). This trial took place in a single institu- tion and involved 400 staff operating on 100 patients underg oing clean and clean-contaminated surgery, who were randomised to the two hand antisepsis groups. Investigators assessed SSI at one month using the CDC de nition. Twenty per cent of the included staff had hand samples sent for microbiological examination, and samples were assessed as positive or negative for hand cultur es. Herruzo 2000 compared three intervention groups: chlorhexidine gluconate scrub versus povidone iodine scrub versus an alcohol rub with N-duopropenide. Each scrub or rub lasted 3 minutes.
We successfully contacted Herruzo 2000 for additional informa- tion regarding sample size. 154 members of the surgical team w ere randomised for 55 operations. Investigators measured CFUs be- fore antisepsis, immediately after antisepsis and at the en d of the surgical procedure. Pietsch 2001 compared scrubbing using 4% chlorhexidine glu- conate (Hibiscrub) with hand rubbing using an alcoholic solu- tion of 45% propanol-2, 30% propanol-1 plus 0.2% ethylhexade- cyldimethyl ammonium ethylsulphate (Sterillium). Seventy- v e 14 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. surgeons from one hospital participated in this randomised cross- over trial, using one product for four weeks then changing to th e alternative product following a rest week. CFUs were measure d before antisepsis, immediately after antisepsis and after the surgi- cal procedure.
Hajipour 2006 compared a 3 minute 4% chlorhexidine gluconate scrub versus a 3 minute chlorhexidine in alcohol rub (Hydrex). We contacted the trial authors, who provided additional study de tails.
Following an aqueous chlorhexidine scrub at the start of each da y, four surgeons were randomised to one or other intervention a nd were evaluated repeatedly in that condition. Testing was carr ied out using the nger press method at the end of each surgical procedur e. Gupta 2007 compared 7.5% povidone iodine aqueous scrub against two alcohol rubs: three 2 ml aliquots of 1% chlorhexidi ne gluconate in 61% ethyl alcohol (Avagard) and a 3 minute appli- cation of zinc pyrithione in 70% ethyl alcohol (Triseptin). The paper does not provide further details regarding the applica tion of the products. Eighteen operating room staff used each of the three products for ve consecutive days. Testing was carried out immediately before and after antisepsis on day one, and at th e end of days two and ve.
Outcomes Surgical site infection (SSI) Aqueous povidone iodine or chlorhexidine gluconate versus 75% propanol-1, propanol-2 plus mecetronium ethylsulphate Parienti 2002 collected data for 30 days following surgery. There was no clear evidence of a difference in the rates of SSI between aqueous scrub and alcohol rub: 2.5% (53/2135) of participants developed an SSI in the scrub group compared with 2.4% (55/ 2252) in the handrub group (RR 1.02, 95% CI 0.70 to 1.48)( Analysis 6.1 ).
Low quality evidence downgraded once due to risk of detectio n bias and once due to imprecision.
Aqueous chlorhexidine gluconate compared with 61% ethyl alcohol plus 1% chlorhexidine gluconate Vergara-Fernandez 2010 found no clear evidence of a difference in SSI rates between groups. In total 2% of participants (1/50) ha d a SSI in the aqueous scrub group compared with 4% (2/50) in the alcohol handrub group (RR 0.50, 95% CI 0.05 to 5.34). The study was small and the resulting 95% CI intervals wide, rang ing from a 95% reduction in risk of SSI to a 400% increased risk of SSI ( Analysis 6.1 ).
Low quality evidence downgraded twice due to imprecision. Number of colony-forming units Aqueous chlorhexidine gluconate versus N-duopropenide Herruzo 2000 reported CFU data (log 10) after antisepsis and af- ter surgery ( Analysis 7.1 ). We were unable to produce an esti- mate of treatment effect for the review. Using bivariate anal ysis, Herruzo 2000 reports that N-duopropenide is more effective than chlorhexidine in reducing the number of CFUs on participants’ hands immediately after antisepsis (P value < 0.01) and at the end of a surgical procedure (P value < 0.01); the paper did not provide any further information on estimates.
Very low quality evidence downgraded twice as precision est i- mates are not available and once due to indirectness of out- come.
Aqueous povidone iodine versus N-duopropenide Herruzo 2000 reported CFU data (log 10) after antisepsis and after surgery ( Analysis 8.1 ). We were unable to produce an estimate of treatment effect for the review. Using bivariate analysis, Herruzo 2000 reports that N-duopropenide was statistically signi cantly more effective than povidone iodine in reducing the number of CFUs on participants hands immediately after antisepsis (P va lue <0.01) and at the end of a surgical procedure (P value <0.01) .
Very low quality evidence downgraded twice as precision est i- mates are not available and once due to indirectness of out- come.
Aqueous chlorhexidine gluconate versus 45% propanol-2, 30% propanol-1 plus 0.2% ethylhexadecyldimethyl ammonium ethylsulphate (Sterillium) Pietsch 2001 reported that rubbing using 45% propanol-2, 30% propanol-1 plus 0.2% ethylhexadecyldimethyl ammonium ethyl - sulphate (Sterillium) was more effective in reducing CFUs on pa r- ticipants’ hands than scrubbing using 4% chlorhexidine glucona te, both immediately after antisepsis (MD 1.27, 95% CI 1.23 to 1.31) and at the end of the surgical procedure (MD 1.07, 95% CI 1.03 to 1.11); Analysis 9.1 .
Moderate quality evidence downgraded once due to indirect- ness of outcome.
Aqueous 4% chlorhexidine gluconate versus 0.5% chlorhexidine gluconate in 70% alcohol Hajipour 2006 reported nding fewer CFUs following an aqueous scrub than after an alcohol rub (MD 135.60, 95% CI 153.39 to 117.81; Analysis 10.1 ). 15 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. This study had a cluster design, in which each surgeon constituted a cluster, giving two clusters in each trial arm. However, the an alysis did not take this into consideration, so the reliability of th e effect estimate reported by the authors is uncertain and could be wide r than reported.
Very low quality evidence downgraded twice due to potential imprecision as re-analysis of data could increase the con de nces intervals and change study conclusions and once due to indi- rectness of outcome.
Aqueous povidone iodine versus 61% ethyl alcohol and 70% ethyl alcohol Gupta 2007 did not present suf cient raw data for us to be able to conduct independent statistical analysis, so we contacted the author to request additional data. In the interim we present Gupta 2007 ’s own analysis. When CFUs were compared collectively from all the sample times, Gupta 2007 reports ’no statistically signi cant difference’ between the solutions (P = 0.21). It must be noted th at this analysis has not been independently veri ed and it is un clear if investigators adjusted this analysis to account for the cros s-over design.
Very low quality evidence downgraded twice for imprecision as CIs not available and twice for indirectness as we were unabl e to assess the actual results and the analysis undertaken and because the outcome is a surrogate outcome.
Comparison 5 summary: Aqueous scrubs compared with alcohol rubs containing additional active ingredients It is unclear if there is a difference in numbers of SSIs between aqueous scrubs and alcohol rubs. The CFU outcome data were varied with two studies nding in favour of the alcohol rubs (mo d- erate and very low quality evidence), one favouring the scrub ar m (very low quality evidence) and one study reporting a ’non-stat is- tically signi cant difference’ with no other data (very low qual ity evidence).
Comparison 6: duration of surgical antisepsis (4 trials) Four trials compared surgical antisepsis of different durati ons but used different antiseptic agents, which prevented us from po oling results ( Kappstein 1993 ;Pereira 1990 ;Pereira 1997 ;Wheelock 1997 ). Wheelock 1997 randomised 25 operating room nurses and surgi- cal technologists to either a 2 minute or a 3 minute scrub. After carrying out the trial scrub, and following a one-week washout period in which they continued to undertake scrubbing as part of their usual work, the participants switched to the other int er- vention. Though the intention of the trial authors was for pa r- ticipants to use aqueous 4% chlorhexidine gluconate (Hibiclens), participants with a history of skin irritation (15/25 particip ants)used either 2% chlorhexidine gluconate or parachlorometaxyle nol (PCMX). CFUs were measured 1 hour after the surgical scrub. Kappstein 1993 compared a ve minute rub with a three minute rub using alcoholic disinfectant. The disinfectant is not iden ti- ed. Both rubs followed 1 minute handwashes using soap and wa - ter. Twenty-four surgeons carried out each of three interventi on groups once in a random order. Samples were taken before and immediately after antisepsis. Pereira 1990 compared a 5 minute initial and 3 minute subsequent scrub with a 3 minute initial and 30 second subsequent scrub usin g chlorhexidine gluconate. Thirty-four participants were rando mly assigned to one of four groups, and each group was assigned to one of four interventions, each lasting one week. Pereira 1990 also compared a 5 minute initial and 3 minute sub- sequent scrub with a 3 minute initial and 30 second subsequent scrub using povidone iodine. Pereira 1997 compared a 5 minute initial and a 3.5 minute subse- quent scrub with a 3 minute initial and a 2.5 minute subsequent scrub using 4% chlorhexidine gluconate. Twenty-three operatin g room nurses were randomised to carry out each of ve interven- tions for one week each.
Outcomes Surgical site infection (SSI) Not reported Number of colony forming units (CFUs) Three minute scrub versus two minute scrub Wheelock 1997 presented paired data, which the review authors re-analysed but did not present. There were fewer CFUs on hand s immediately after a 3 minute scrub compared with a 2 minute scrub (MD 0.29, 95% CI 0.06 to 0.52).
Very low quality evidence downgraded once due to risk of de- tection bias and twice due to indirectness, once due to indir ect- ness of outcome and once because the intervention was used in the absence of surgery being conducted.
Five minute rub versus three minute rub (Analysis 11.1) Kappstein 1993 favoured the 3 minute scrub over the 5 minute scrub when assessed immediately after antisepsis (MD 0.26, 95 % CI 0.14 to 0.38; Analysis 11.1 ). Because the use of a cross-over design was not accounted for in the analysis the true con dence intervals may be narrower than those reported here. 16 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Low quality evidence: downgraded once due to imprecision and once due to indirectness.
Five minute initial and three minute subsequent scrub versu s three minute initial and 30 second subsequent scrub using chlorhexidine (Analysis 12.1) Pereira 1990 reported no clear difference between groups in the number of CFUs immediately after the initial scrub (MD 0.19, 95% CI 0.51 to 0.13) or 2 hours after the initial scrub (MD 0.23, 95% CI 0.52 to 0.06). There was evidence of a difference in CFUs favouring the 5 minute arm 2 hours after the subsequen t scrub (MD 0.58, 95% CI 0.92 to 0.24); see Analysis 12.1 .
Very low quality evidence down graded twice due to imprecisi on and once due to indirectness of outcome.
Five minute initial and three minute subsequent scrub compared with a three minute initial and 30 second subsequent scrub using povidone iodine (Analysis 13.1) In Pereira 1990 , there was no clear difference in the number of CFUs at any time point, whether immediately after the initia l scrub (MD 0.02, 95% CI 0.28 to 0.32), 2 hours after the initial scrub (MD 0.12, 95% CI 0.21 to 0.45) or 2 hours after the subsequent scrub (MD 0.13, 95% CI 0.37 to 0.11); see Analysis 13.1 .
V ery low quality evidence downgraded due to imprecision and indirectness of outcome.
Five minute initial and three and 30 second subsequent scrub compared with a three minute initial and two and a half minute subsequent scrub using chlorhexidine (Analysis 14.1) In Pereira 1997 , there was no clear difference in the number of CFUs at any time point reported, whether immediately after t he initial antisepsis (MD 0.08, 95% CI 0.44 to 0.60), 2 hours after the initial antisepsis (MD 0.19, 95% CI 0.78 to 0.40) or 2 hours after subsequent antisepsis (MD 0.17, 95% CI 0.71 to 0.37); see Analysis 14.1 .
Very low quality evidence due to risk of bias of attrition bia s; imprecision and indirectness of outcome.
Comparison 6 summary: duration of surgical antisepsis Outcome data were only available for CFUs. One study reported evidence of fewer CFUs on hands after using a 3 minute rather th an 2 minute chlorhexidine scrub. Another study reported fewer CF Us after a 3 minute alcohol rub compared with a 5 minute alcohol rub; evidence was low quality in both cases. One study reported that 3 minute subsequent scrubs with aqueous chlorhexidine (followi nginitial scrubs) were more effective in reducing the number of CF Us on hands than 30 second subsequent scrubs; this difference was n ot observed with povidone iodine treatments used in the same wa y:
estimates from this study was classed as being of very low qual ity.
Other comparisons reported no clear differences in number of CFUs.
Comparison 7: surgical hand antisepsis using a nail pick versus surgical hand antisepsis not using a nail pick (1 trial) One three-arm trial compared the effect of surgical hand antisep sis using a nail pick with surgical hand antisepsis alone ( Tanner 2009 ).
The study randomised 164 participants to one of three groups.
All groups scrubbed with two measured doses of 2 ml aqueous chlorhexidine gluconate 4% (Hibiscrub) for 1 minute per dose; the total scrub time, which was observed and timed, was 2 minute s.
One group performed only this surgical hand antisepsis. A seco nd group used a disposable nail pick to clean their nails under run ning water before the hand antisepsis procedure. The third group u sed a disposable nail brush to clean their nails under running wat er before the hand antisepsis procedure. Participants then unde rtook circulating duties in the operating room for one hour but did no t participate in any surgeries.
Outcomes Surgical site infection Not reported Number of colony forming units (CFUs) There was no clear evidence of a difference between nail pick and no nail pick in the number of CFU detected after one hour on the dominant hands of participants (MD 0.13, 95% CI 0.14 to 0.40; Analysis 15.1 ).
Very low quality evidence - downgraded once due to imprecisi on and once due to indirectness of outcome and further again for indirectness as no surgery was performed.
Comparison 8 surgical hand antisepsis using a brush versus surgical hand antisepsis not using a brush (1 trial) In the same three-arm trial ( Tanner 2009 ) compared the effect of surgical hand antisepsis and using a brush with surgical han d antisepsis alone. Participants were allocated to groups as de scribed above. There was no clear evidence of a difference between using and not using a brush during hand antisepsis on the number of CFUs (MD 0.24, 95% CI -0.04 to 0.51; Analysis 16.1 ). 17 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Very low quality evidence; downgraded once due to imprecision and once due to indirectness of outcome and further again for indirectness as no surgery was performed.
Comparison 9: surgical hand antisepsis using a nail pick versus surgical hand antisepsis using a brush (1 trial) In the same three-arm trial ( Tanner 2009 ) compared the effect of surgical hand antisepsis using a nail pick with surgical hand antisepsis using a brush. There was no difference in the numbe r of CFUs detected after 1 hour on the dominant hands of participant swho used a brush before hand antisepsis compared with those wh o used a nail pick before hand antisepsis (MD 0.10, 95% CI -0.17 to 0.37; Analysis 17.1 ).
Very low quality evidence - downgraded once due to imprecisi on and once due to indirectness of outcome and further again for indirectness as no surgery was performed.
Summary of Comparisons 7 to 9: Surgical hand antisepsis using a nail pick and brush There was no clear evidence of a difference in CFUs when a nail pick was compared with a brush or with no pick or brush.
Brief overview of ndings Comparison Evidence SSI GRADE ASSESSMENT CFUs (on hands) GRADE ASSESSMENT Comparison 1 :
basic hand hygiene versus alcohol rub contain- ing additional active ingredients 1 study There was no clear evidence of a differ- ence between treat- ments: RR 0.97 (95% CI 0.77 to 1.23) ( Nthumba 2010 ) Moderate quality evi- dence Not reported - Comparison 2 :dif- fer- ent aqueous scrub solutions: chlorhex- idine gluconate ver- sus povidone iodine 4 studies Not reported - In 4 comparisons (3 stud- ies: Furukawa 2005 ; Herruzo 2000 ;Pereira 1990 ), there was evi- dence of lower CFU counts immediately following scrubs with chlorhexidine, and in Pereira 1990 , also after subsequent scrubbing.
In 1 comparison (1 study) there was no evidence of a differ- ence in the CFU count between an aqueous scrub of chlorhexidine gluconate and an aque- ous scrub of povidone iodine plus triclosan ( Pereira 1997 ). Low quality evidence for Furukawa 2005 and Herruzo 2000 and very low quality evi- dence for Pereira 1990 and Pereira 1997 Com- parison 3 : compar- ison of different al- cohol rubs contain- ing additional active ingredients 2 studies Not reported - 1 study reported small mean difference val- ues with imprecision around estimates at the 3 time points re- Very low quality evi- dence 18 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) ported ( Pereira 1997 ) . We could not ver- ify the ndings of 1 study, which study au- thors reported as not statistically signi cant ( Gupta 2007 ). Com- parison 4 : aqueous scrubs versus alco- hol-only rubs 1 study RR 0.56 (95% CI 0.
23 to 1.34) ( Al-Naami 2009 ) The estimates was im- precise, and it was not possible to rule out an effect in either direc- tion Very low quality evi- dence Not reported - Com- parison 5 : aqueous scrubs versus alco- hol rubs containing additional active in- gredients 6 studies 2 studies reported SSI data:
RR 1.02, 95% CI 0.70 to 1.48 ( Parienti 2002 ) RR 0.56, 95% CI 0.
05 to 5.34 ( Vergara- Fernandez 2010 ) Both estimates were imprecise, and it was not possible to rule out an effect in either di- rection Low quality evidence Reported for 5 sub- comparisons based on product type In 3 sub-comparisons (2 studies), there was evidence that an alco- hol rub with added in- gredient reduced the CFU count on the hands compared to aqueous scrubs (differ- ent types) immediately after antisepsis and at the end of the surgi- cal procedure ( Pietsch 2001 ;Herruzo 2000 ).
One sub-com- parison (1 study) sug- gested that the aque- ous scrub was more effective in reducing CFUs than the alcohol rub with added ingre- dient ( Hajipour 2006 ) .
One sub-comparison (1 study) suggested no evidence of a differ- ence between inter- ventions ( Gupta 2007 ) . Moderate quality ev- idence for Pietsch 2001 , and very low quality for Hajipour 2006 ,Herruzo 2000 and Gupta 2007 19 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Comparison 6 : du- ration of surgical an- tisepsis 4 studies Not reported - 3 min versus 2 min scrub : evidence of fewer CFUs in 3 min scrub group immedi- ately after scrubbing (MD 0.29, 95% CI 0.
06 to 0.52; Wheelock 1997 ) 5 min scrub versus 3 min scrub : evidence of fewer CFUs immedi- ately after scrubbing in the 3 min group (MD 0.26, 95% CI 0.14 to 0.38; Kappstein 1993 ) 5 min ini- tial and 3 min subse- quent scrub versus a 3 min initial and 30 s subsequent scrub :
Chlorhexidine scrub :
evidence of fewer CFUs in the longer scrub duration group after the subse- quent scrubs ( Pereira 1990 ) Povidone iodine scrub : no evidence of a difference in CFUs between groups at any stage ( Pereira 1990 ) 5 min initial and 3.5 min subsequent scrub versus a 3 min initial and 2.5 min subsequent scrub us- ing chlorhexidine : no evidence of a differ- ence in CFUs at any stage ( Pereira 1997 ) Low quality evidence for Kappstein 1993 and very low quality evidence for Pereira 1990 , Pereira 1997 and Wheelock 1997 Comparison 7 : sur- gical hand antisepsis using a nail pick ver- sus surgical hand an- tisepsis not using a nail pick 1 study Not reported - Mean difference in CFUs 1 h after antisep- sis was 0.13 (95% CI 0.14 to 0.40; Tanner 2009 ). No clear evi- dence of a difference. Very low quality evi- dence 20 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Comparison 8 : sur- gical hand antisep- sis using a brush ver- sus surgical hand an- tisepsis not using a brush 1 study Not reported - Mean difference in CFUs 1 h after antisep- sis was 0.24 (95% CI 0.04 to 0.51; Tanner 2009 ). No clear evi- dence of a difference. Very low quality evi- dence Comparison 9 : sur- gical hand antisep- sis using a nail pick versus surgical hand antisepsis using a brush 1 study Not reported - Mean difference in CFUs 1 h after antisep- sis was 0.10 (95% CI 0.17 to 0.37; Tanner 2009 ). No clear evi- dence of a difference. Very low quality evi- dence D I S C U S S I O N Summary of main results Fourteen trials met the inclusion criteria and were included in this review.
Only four trials reported risk of surgical site infection (SSI), the primary outcome for this review ( Al-Naami 2009 ;Nthumba 2010 ; Parienti 2002 ;Vergara-Fernandez 2010 ). These results were in- conclusive, and it is not clear whether any method of hand anti- sepsis is any more effective than another in reducing subseque nt SSI. Most of the evidence was of low or very low quality, mainly due to risk of bias and imprecision. Most of the studies were to o small to detect a difference in SSI rates even if one existed.
The remaining 10 trials measured the number of CFUs on hands.
Where trials were cluster and/or crossover trials they were oft en not analysed correctly, which may impact on the precision of estimate s.
In four comparisons of aqueous scrub solutions containing chlorhexidine versus those containing povidone iodine, (thre e studies) there was evidence that chlorhexidine-gluconate conta in- ing scrubs reduce numbers of CFU on the hands more than povi- done iodine ( Furukawa 2005 ;Herruzo 2000 ;Pereira 1990 ). The evidence was of low or very low quality. High levels of heterog ene- ity precluded meta-analysis.
Results of studies comparing alcohol rubs with aqueous scrubs were mixed. In three comparisons (two studies) alcohol rubs con- taining additional active ingredients were found to be more e f- fective than aqueous scrubs in reducing the number of CFUs on hands (moderate and very low quality evidence) ( Herruzo 2000 ; Pietsch 2001 ).Gupta 2007 reported no difference between povi- done iodine scrubs and ethyl alcohol based rubs of 61% and 70% (very low quality evidence). Hajipour 2006 found chlorhexidine aqueous scrubs more effective than chlorhexidine in alcohol rub s (very low quality evidence).
In terms of the duration of hand antisepsis, there was eviden ce that a 3 minute scrub reduced the number of CFUs compared to a 2 minute scrub ( Wheelock 1997 ) (very low quality evidence). Data on other comparisons were not consistent, and interpretation is dif cult.
One three-arm trial assessed the use of a disposable nail pick o r disposable nail brush under running water prior to scrubbing with chlorhexidine and found no clear difference in the number of CFUs (very low quality evidence) ( Tanner 2009 ). Nthumba 2010 , which found no difference in SSIs when com- paring surgical hand antisepsis with basic hand hygiene (mode rate quality evidence), has interesting implications for practice, w hich warrant further research.
Quality of the evidence Surgical hand antisepsis is carried out to reduce the number of bacteria on the hands of the surgical team so that in the event of a breach in glove barrier protection, the risk of transferring in- fections to patients is reduced. Therefore, the most appropri ate outcome measure for a study of surgical hand antisepsis is post op- erative SSI. Only four studies used this measure ( Al-Naami 2009 ; Nthumba 2010 ;Parienti 2002 ;Vergara-Fernandez 2010 ), while the remaining 10 trials measured CFUs. It is widely assumed t hat interventions reducing CFUs may impact on incidence of SSIs but there is little evidence to support this assertion. There was considerable variation in the timing of outcome assessment fo r measuring CFUs as well as some differences in the methods used to obtain samples.
All of the studies included in this review were underpowered i n 21 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. terms of small sample sizes, a limited number of outcome events or both. RCTs need to be adequately powered so that they are able to detect treatment effects of a speci ed size if they exist , and sample size calculations should be used to help estimate the nu m- ber of people recruited to a trial. Evidence from limited numbe rs of participants and/or where limited numbers of events occur can also lead to con dence intervals that are fragile (that is not st able) which is also likely to have been a risk for all comparisons here .
A key issue with the included studies was the incorrect or unclear analysis and presentation of cross-over and cluster data. When these methods are used, correct planning, conduct and reporting are vital to maximise the value of the research. Cross-over stu dies involve an individual receiving more than one of the treatmen ts of interest, with the randomisation consisting of the sequen ce in which these are received. The analysis requires statistical te sts that take the paired nature of these data into account. If investiga tors do not use these approaches, they may overestimate standard err ors, leading to con dence intervals which are less precise than they might be - that is, there is a risk of a type II error (concluding no signi cant difference when there is one). Cluster trials, wh ere allocation of treatment is made at a group level and the unit of assessment is at the individual level, require careful plann ing and analysis to avoid producing arti cially small standard error s which can lead to type I errors - that is, nding a statistical signi ca nt difference when one does not exist.
Potential biases in the review process We attempted to overcome potential publication bias through r ig- orous searching. We had two studies translated, one from Ger- man and one from Spanish ( Kappstein 1993 ;Vergara-Fernandez 2010 ). Five other trials also took place in countries where English i s not the rst language: Al-Naami 2009 in Saudi Arabia, Furukawa 2005 in Japan, Herruzo 2000 in Spain, Nthumba 2010 in Kenya and Pietsch 2001 in Germany.
We attempted to contact seven trial authors for additional inf or- mation ( Gupta 2007 ;Hajipour 2006 ;Herruzo 2000 ;Kappstein 1993 ;Pereira 1997 ;Pietsch 2001 ;Sensoz 2003 ). Five authors re- sponded ( Hajipour 2006 ;Herruzo 2000 ;Kappstein 1993 ;Pereira 1997 ;Sensoz 2003 ). We included six of these trials in the review ( Gupta 2007 ;Hajipour 2006 ;Herruzo 2000 ;Kappstein 1993 ; Pereira 1997 ;Pietsch 2001 ). For the update we excluded Sensoz 2003 , as there were no indications from the publication that par- ticipants were randomised, and we were unable to obtain infor - mation to the contrary. For the update we attempted to contact one author ( Chen 2012 ); this trial is awaiting assessment.
Four trials acknowledged the role of commercial companies in supplying antiseptic products ( Parienti 2002 ;Pereira 1990 ;Pereira 1997 ;Vergara-Fernandez 2010 ), and one trial was led by a research employee of a commercial company ( Pietsch 2001 ).Tanner 2009 reported funding from a commercial company. As the lead author of this review was also an author on an included study ( Tanner 2009 ), two other authors independently extracted data from it and drafted related review text to minimise any bias.
Agreements and disagreements with other studies or reviews This updated review differs from the earlier review as it incl udes an additional four studies ( Al-Naami 2009 ;Nthumba 2010 ;Tanner 2009 ;Vergara-Fernandez 2010 ). However the addition of these new studies did not result in a change to the ndings of the earl ier review.
We identi ed two other systematic reviews of surgical hand an ti- sepsis ( Goncalves 2012 ;Hsieh 2006 ). We discussed Hsieh 2006 in the earlier version of this Cochrane review, but Goncalves 2012 , published in 2012, is new to this update. Goncalves 2012 included 23 studies and two systematic reviews (the previous version o f this Cochrane review and Hsieh 2006 ), focusing on traditional scrubs versus alcohol rubs. It included randomised trials, non - randomised trials, cohort studies, case-control studies, descr iptive studies and case reports. Goncalves 2012 included six randomised studies which fell within the search dates of this update revie w but are excluded from this review ( Larson 1990 ;Hobson 1998 ; Mulberry 2001 ;Larson 2001b ;Marchetti 2003 ;Rotter 2006 ); Goncalves 2012 also included one unpublished study that we were unable to retrieve ( Sigler 2001 ). However, we did include three of the same randomised studies ( Pietsch 2001 ;Parienti 2002 ;Gupta 2007 ).Goncalves 2012 concluded that alcohol preparations can replace traditional scrubs using aqueous chlorhexidine or iod ine. Hsieh 2006 was published in 2006 and includes three trials ( Bryce 2001 ;Larson 2001b ;Wheelock 1997 ). This Cochrane review up- date also included Wheelock 1997 but excluded Bryce 2001 and Larson 2001b , as they were not randomised. Hsieh 2006 failed to identify six of the eight trials published before 2006 tha t were included in this Cochrane review ( Furukawa 2005 ;Herruzo 2000 ; Kappstein 1993 ;Pereira 1990 ;Pereira 1997 ;Pietsch 2001 ), and they excluded Parienti 2002 because it measured SSIs rather than CFUs. Hsieh 2006 draws two conclusions: that surgical handrubs using alcohol-based products are more effective than 6 minute scrubs using 4% chlorhexidine, and that there is no evidence tha t a 2 minute scrub is more effective than a 3 minute scrub using 4% chlorhexidine.
Guidelines for hand antisepsis have changed slightly since th e rst version of this Cochrane review was published. The main change s are the increasing status of alcohol rubs, which are now consider ed to have equal standing to traditional scrubs and are acceptable alternatives ( AfPP 2011 ;ACORN 2012 ); and the use of brushes which has been downgraded from not necessary to not recom- mended ( AfPP 2011 ;ACORN 2012 ).
The conclusions one can draw from the evidence in this review are limited for the following reasons. Ten of the 14 trials in cluded in this review measured CFUs rather than SSIs ( Furukawa 2005 ; Gupta 2007 ;Hajipour 2006 ;Herruzo 2000 ;Kappstein 1993 ; 22 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pereira 1990 ;Pereira 1997 ;Pietsch 2001 ;Tanner 2009 ;Wheelock 1997 ). Two of these trials used the nger press method rather than the recognised standard glove juice test ( Hajipour 2006 ;Herruzo 2000 ). Sample sizes are small in most of the trials. In three trials , participants in the scrub group had a choice of antiseptic soluti ons ( Al-Naami 2009 ;Parienti 2002 ;Wheelock 1997 ), and details of the randomisation are poor in many of the trials.
A U T H O R S ’ C O N C L U S I O N S Implications for practice Uncertainty remains about the optimal method of hand antisep sis for minimising SSI outcomes: only four studies reported this out- come, and they were heterogeneous, at high risk of bias and mai nly greatly underpowered. For the secondary (and surrogate) outco me of the number of CFUs on the hands, there is some generally low or very low quality evidence that quality chlorhexidine aqueo us scrubs may reduce CFUs compared with povidone iodine aque- ous scrubs and that an alcohol rub with added ingredient reduced the number of CFUs on the hand compared with aqueous scrubs (different types) immediately after antisepsis and at the en d of the surgical procedure. The evidence regarding the impact of using a nail pick or brush on CFUs is unclear. In terms of duration of antisepsis, scrubbing for 3 minutes rather than 2 minutes may lead to fewer CFUs on the hand (low or very low quality evidence).
Other data are more dif cult to interpret.
Implications for research Trials should attempt to measure the impact of hand antisepsi s on SSIs. Investigators should also adhere to a recognised de ni- tion of SSI, which includes a 30 day follow-up. Trials should use adequate sample sizes based on a priori sample size calculatio ns and take account of any data cross-over and/or clustering. The following trials might address important clinical questions - theseand related uncertainties should be prioritised in conjunctio n with health professionals and policy makers. Future studies shou ld be adequately designed and powered.
Antisepsis compared with standard handwashing approaches.
Relative effectiveness of aqueous scrubs versus alcohol rubs (outcome SSI).
Optimum duration of aqueous scrubs (outcome SSI).
Optimum duration of alcohol rubs (outcome SSI).
Brushes, nail picks and sponges compared with no brushes, nail picks or sponges (outcome SSI).
A C K N O W L E D G E M E N T S The authors would like to thank Cochrane Wounds Group peer referees (Vickie Arrowsmith, Roy Buffery, Seokuyng Hahn, An ne Humphreys, Anita Kainth, Rachel Richardson and John Tim- mons); Editors (Nicky Cullum and Andrea Nelson) Mieke Flour, Raj Mani and Managing Editor Sally Bell-Syer for their comment s to improve the review.
For this update the authors also thank Sonya Osborne for com- ments as referee and Rocio Rodriguez Lopez and Jennifer Brown for their assistance with papers in Spanish and German. Jean S tu- art, Sandra Swarbook, Wendy Padley and Nathorn Chaiyaku- naprik all contributed to the original review and we would lik e to acknowledge their contribution although they were not involv ed in the production of this update. Thanks to Meggan Harris who copy edited this version of the review.
This work was supported by a grant from the National Institut e for Health Research, UK (NIHR Cochrane programme Grant 13/89/ 08- High Priority Cochrane Reviews in Wound Prevention and Treatment).
R E F E R E N C E S References to studies included in this review Al-Naami 2009 {published data only} Al-Naami MY, Anjum MN, Afzal MF, Al-Yami MS, Al- Qahtani SM, Al-Dohayan AD, et al. Alcohol-based hand- rub versus traditional surgical scrub and the risk of surgical site infection: a randomized controlled equivalent trial.
EWMA Journal 2009;9(3):5–10.
Furukawa 2005 {published data only} Furukawa K, Tajiri T, Sudzuki H, Norose Y. Are sterile water and brushes necessary for hand washing before surgery in Japan?.
Journal of Nippon Medical School 2005;72(3):
149–54.
Gupta 2007 {published data only} Gupta C, Czubatyj AM, Briski LE, Malani AK. Comparison of two alcohol-based surgical scrub solutions with an iodine- based brush for presurgical antiseptic effectiveness in a community hospital. Journal of Hospital Infection 2007;65 (1):65–71.
Hajipour 2006 {published and unpublished data} Hajipour L, Longstaff C, Cleeve V, Brewster N, Bint D, Henman P. Hand washing rituals in trauma theatre: clean 23 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. or dirty?.Annals of the Royal College of Surgeons of England 2006; 88(1):13–5.
Herruzo 2000 {published and unpublished data} Herruzo Cabrera R, Vizcaino Alcaide MJ, Fdez Acinero MJ.
Usefulness of an alcohol solution of N-duopropenide for the surgical antisepsis of the hands compared with handwashing with iodine povidone and chlorhexidine. Journal of Surgical Research 2000;94(1):6–12.
Kappstein 1993 {published data only} Kappstein I, Schulgen G, Waninger J, Daschner F.
Microbiological and economic studies of abbreviated procedures for surgical hand disinfection [Mikrobiologisch e und okonomische Untersuchungen uber verkurzte Verfahen fur die chirurgische Handedesinfektion]. Der Chirurg1993; 64 (5):400–5.
Nthumba 2010 {published data only} Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, et al. Cluster-randomized, crossover trial of the ef cacy of plain soap and water versus alcohol- based rub for surgical hand preparation in a rural hospital in Kenya. British Journal of Surgery 2010;97(11):1621–8.
Parienti 2002 {published data only} Parienti JJ, Thibon P, Heller R, Le Roux Y, Theobald P, Bensadoun H, et al. Hand-rubbing with an aqueous alcoholic solution vs traditional surgical hand-scrubbing and 30-day surgical site infection rates. JAMA2002;288 (6):722–7.
Pereira 1990 {published data only} Pereira LJ, Lee GM, Wade KJ. The effect of surgical handwashing routines on the microbial counts of operating room nurses. American Journal of Infection Control 1990;18 (6):354–64.
Pereira 1997 {published and unpublished data} Pereira LJ, Lee GM, Wade KJ. An evaluation of ve protocols for surgical handwashing in relation to skin condition and microbial counts. Journal of Hospital Infection 1997; 36(1):49–65.
Pietsch 2001 {published data only} Pietsch H. Hand antiseptics: rubs versus scrubs, alcoholic solutions versus alcoholic gels. Journal of Hospital Infection 2001; 48(Suppl A):S33–6.
Tanner 2009 {published data only} Tanner J, Khan D, Walsh S, Chernova J, Lamont S, Laurent T. Brushes and picks used on nails during the surgical scrub to reduce bacteria: a randomised trial. Journal of Hospital Infection 2009;71(3):234–8.
Vergara-Fernandez 2010 {published data only} Vergara-Fernandez O, Morales-Olivera JM, Ponce-de- Leon-Rosales S, Vega-Batista R, Mejfa-Ovaile R, Huertas- Jimenez M. Surgical team satisfaction levels between two preoperative hand-washing methods [Niveles de satisfacción del equipo quirúrgico entre dos métodos de lavado de mano]. Revista de Investigación Clínica 2010;62(6):532–7. Wheelock 1997 {published data only} Wheelock SM, Lookinland S. Effect of surgical hand scrub time on subsequent bacterial growth. AORN Journal1997; 65 (6):1087–98.
References to studies excluded from this review Adjoussou 2009 {published data only} Adjoussou S, Konan Blé R, Séni K, Fanny M, Toure-Ecra A, Kof A, et al. Value of hand disinfection by rubbing with alcohol prior to surgery in a tropical setting [Intérêt de la désinfection chirugicale des mains par friction alcoolique e n milieu tropical]. Médicine Tropicale 2009;69(5):463–6.
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Postgraduate Medical Journal 1993;69(Suppl 3):S93–6.
Ayliffe 1984 {published data only} Ayliffe GAJ. Surgical scrub and skin disinfection. Infection Control 1984;5(1):23–7.
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Ayliffe 1990 {published data only} Ayliffe GAJ, Babb JR, Davies JG, Newsom SWB, Rowland C, Platt JH, et al. Hygienic hand disinfection tests in three laboratories. Journal of Hospital Infection 1990;16(2):
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Babb 1991 {published data only} Babb JR, Davies JG, Ayliffe GAJ. A test procedure for evaluating surgical hand disinfection. Journal of Hospital Infection 1991;18(Suppl B):41–9.
Bansal 2002 {published data only} Bansal BC, Wiebe RA, Perkins SD, Abramo TJ. Tap water for irrigation of lacerations. American Journal of Emergency Medicine 2002;20(5):469–72.
Barsanti 2009 {published data only} Barsanti MC, Woeltje KF. Infection prevention in the Intensive Care Unit. Infectious Diseases Clinics of North America 2009;23(3):703–25. 24 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Bartzokas 1983{published data only} Bartzokas CA, Gibson MF, Graham R, Pinder DC. A comparison of triclosan and chlorhexidine preparations with 60% isopropyl alcohol for hygienic hand disinfection.
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Beeuwkes 1986 {published data only} Beeuwkes H, De Rooij SH. Microbiological tests on operating theatre staff of a new disinfectant foam based on 1% chlorhexidine gluconate. Journal of Hospital Infection 1986; 8(2):200–2.
Bendig 1990 {published data only} Bendig JWA. Surgical hand disinfection: comparison of 4% chlorhexidine detergent solution and 2% triclosan detergent solution. Journal of Hospital Infection 1990;15(2):143–8.
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Blomgren 1983 {published data only} Blomgreng, Hambraeus A, Malmborg AS. The in uence of the total body exhaust suit on air and wound contamination in elective hip operations. Journal of Hospital Infection 1983; 4 (3):257–68.
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Coelho 1984 {published data only} Coelho JCU, Lerner H, Murad I. The in uence of the surgical scrub on hand bacterial ora. International Surgery 1984; 69(4):305–7.
Cremieux 1989 {published data only} Cremieux A, Reverdy ME, Pons JL, Savage C, Chevalier J, Fleurette J, et al. Standardised method for evaluation of hand disinfection by surgical scrub formulations. Applied and Environmental Microbiology 1989;55(11):2944–8.
Crowder 1967 {published data only} Crowder VH, Welsh JS, Bornside GH, Cohn I. Bacterial comparison of hexachlorophen and polyvinylpyrrolideone iodine surgical scrub soaps. The American Surgeon1967;33 (11):906–11.
Culligan 2005 {published data only} Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomised trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy.
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Curti 1974 {published data only} Curti Junior A, Pagani C. Use of chemical agents germ hand, germekil, savlon and valmicid GI in disinfection of rubber dam as an integral part of total isolation of the 25 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. surgical eld [O uso dos agentes químicos germ hand, germekil instrumental, savlon e valmicid GI na desinfecção do lencol de borracha odontológico como parte integrante do isolamento absoluto do campo operatório].Ars curandi Em Odontologia 1974;1(3):56–60.
Da Cunha 2011 {published data only} Da Cunha ER, De Oliveira Azevedo Matos FG, Da Silva AM, De Araujo EAC, Ferreira KA, Graziano KU. The ef cacy of three hand asepsis techniques using chlorhexidine gluconate (CHG 2%) [E cácia de três métodos de degermação das mãos utilizando Gluconato de clorexidina degermante (GCH 2%)]. Revista da Escola de Enfermagem da USP 2011;45(6):1440–5.
Dahl 1990 {published data only} Dahl J, Wheeler B, Muhkerjee D. Effect of chlorhexidine scrub on postoperative bacterial counts. American Journal of Surgery 1990;159(5):486–8.
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Surgical Infections 2006;7(Suppl 1):S13–7.
Durani 2008 {published data only} Durani P, Leaper D. Povidone-iodine: use in hand disinfection, skin preparation and antiseptic irrigation.
International Wound Journal 2008;5(3):376–87. Elenbaas 1982 {published data only} Elenbaas RM, McNabney WK, Robinson WA. Prophylactic oxacillin in dog bite wounds. Annals of Emergency Medicine 1982; 11(5):248–51.
Ellenhorn 2005 {published data only} Ellenhorn JD, Smith DD, Schwartz RE, Kawachi MH, Wilson TG, McGonigle KF, et al. Paint-only is equivalent to scrub and paint in preoperative preparation of abdominal surgery. Journal of the American College of Surgeons 2005; 201 (5):737–41.
Faoagali 1995 {published data only} Faogali J, Fong J, George N, Mahoney P, O’Rourke V.
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Ford 2005 {published data only} Ford, HR, Jones P, Gaines B, Reblock K, Simpkins DL.
Intraoperative handling and wound healing: controlled clinical trial comparing coated VICRYL plus antibacterial suture (coated polyglactin 910 suture iwth triclosan) with coated VICRYL suture (coated polyglactin 910 suture).
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Grabsch 2004 {published data only} Grabsch EA, Mitchell DJ, Hooper J, Turnidge JD. In- use ef cacy of a chlorhexidine in alcohol surgical rub: a comparative study. Australia and New Zealand Journal of Surgery 2004;74(9):769–72.
Grinbaum 1995 {published data only} Grinbaum RS, De Mendonca JS, Cardo DM. An outbreak of hand scrubbing related surgical site infections in vascular surgical procedures. Infection Control and Hospital Epidemiology 1995;16(4):198–202.
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Guilhermetti 2001 {published data only} Guilhermetti M, Hernandes SE, Fukushigue Y, Garcia LB, Cardoso CL. Effectiveness of hand-cleaning agents for removing methicillin-resistant Staphylococcus aureus from contaminated hands. Infection Control and Hospital Epidemiology 2001;22(2):105–8.
Hagen 1995 {published data only} Hagen KS, Treston Aurand J. A comparison of two skin preps using in cardiac surgical procedures. AORN Journal 1995; 62(3):393–402.
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BMC Infectious Diseases 2014;14:315. [DOI: 10.1186/ 1471-2334-14-315] 26 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Heeg 1986{published data only} Heeg P, Osswald W, Schwenzer N. A trial on the ef cacy of various surgical hand disinfection method under experimental and clinical conditions [Wirksamkeitsvergleich von desinfektionsverfahren zur chirurgischen handedesinfektion unter experimentellen und klinischen bedingungen]. Hygiene + Medizin1986;11(3):
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Hibbard 2002a {published data only} Hibbard JS, Mulbery GK, Brady AR. A clinical study comparing the skin antisepsis and safety of chloraprep, 70% isopropyl alcohol and 2% aqueous chlorhexidine. Journal of Infusion Nursing 2002;25(4):244–9.
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Hingst 1992 {published data only} Hingst V, Juditzki I, Heeg P, Sonntag HG. Evaluation of the ef cacy of surgical hand disinfection following a reduced application time of 3 instead of 5 min. Journal of Hospital Infection 1992;20(2):79–86.
Hobson 1998 {published data only} Hobson DW, Woller W, Anderson L, Guthery E.
Development and evaluation of a new alcohol-based surgical hand scrub formulation with persistent antimicrobial characteristics and brushless application. American Journal of Infection Control 1998;26(5):507–12.
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Jeng 1998 {published data only} Jeng DK, Severin JE. Povidone iodine gel alcohol: a 30 second, one time application preoperative skin preparation.
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Jones 2000 {published data only} Jones RD, Jampani H, Mulberry G, Rizer RL. Moisturing alcohol hand gels for surgical hand preparation. AORN Journal 2000;71(3):584-7, 589-90, 592.
Joress 1962 {published data only} Joress SM. A study of disinfection of the skin. Annals of Surgery 1962;155(2):296–304.
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Alcohol for surgical scrubbing. Infection Control Hospital Epidemiology 1990;11:139–43.
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Lio 2009 {published data only} Lio PA, Kaye ET. Topical antibacterial agents. Infectious Disease Clinics of North America 2009;23(4):945–63.
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Loeb 1997 {published data only} Loeb MB, Wilcox L, Smaill F, Walter S, Duff Z. A randomized trial of surgical scrubbing with a brush compared to antiseptic soap alone. American Journal of Infection Control 1997;25(1):11–5.
Lowbury 1974a {published data only} Lowbury E, Lilly H. The effect of blood on disinfection of surgeon’s hands. British Journal of Surgery 1974;61(1):
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Lowbury 1974b {published data only} Lowbury EJL, Lilly HA, Ayliffe GAJ. Preoperative disinfection of surgeons’ hands: use of alcoholic solutions and effects of gloves on skin ora.
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Lung 2004 {published data only} Lung DC, Man JHK, Tang THC, Wong LKY, Leung GKK.
Surgical hand washing. Annals of the College of Surgeons of Hong Kong 2004;8(3):71–5.
Magann 1993 {published data only} Magann EF, Dodson MK, Ray MA, Harris RL, Martin JN, Morrison JC. Preoperative skin preparation and intraoperative pelvic irrigation: impact on post-Cesarean endometritis and wound infection. Occupational Therapy Journal of Research 1993;81(6):922–5.
Magera 2007 {published data only} Magera JS, Inman BA, Elliott DS. Does preoperative topical antimicrobial scrub reduce positive surgical site culture r ates in men undergoing arti cial urinary sphincter placement?
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Evaluation of the bactericidal effect of ve products for surgical hand disinfection according to prEN 12054 and prEN12791. Journal of Hospital Infection 2003;54(1):
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Mathias 2000 {published data only} Mathias JM. Sould we discard ritual of scrubbing with brush?. OR Manager 2000;16(9):20–2.
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McBride 1973 {published data only} McBride ME, Duncan WC, Knox JM. An evaluation of surgical scrub brushes. Surgery, Gynecology and Obstetrics 1973; 137(6):934–6.
Meers 1978 {published data only} Meers PD, Yeo GA. Shedding of bacteria and skin squames after handwashing. Journal of Hygiene1978;81(1):99–105.
Minakuchi 1993 {published data only} Minakuchi K, Yamamoto Y, Matsunaga K, Hayata M, Yasuda T, Katsuno Y, et al. The antiseptic effect of a quick drying rubbing type povidone iodine alcoholic disinfectant solution. Postgraduate Medicine 1993;69(Suppl 3):S23–6.
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23–30. 28 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Moralejo 2003{published data only} Moralejo D, Jull A. Handrubbing with an alcohol based solution reduced healthcare workers’ hand contamination more than handwashing with antiseptic soap. Evidence based Nursing 2003;6(2):54.
Mulberry 2001 {published data only} Mulberry G, Snyder AT, Heilman J, Pyrek J, Stahl J.
Evaluation of a waterless, scrubless chlorhexidine gluconate / ethanol surgical scrub for antimicrobial ef ciency. American Journal of Infection Control 2001;29(6):377–82.
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O’Shaughnessy 1991 {published data only} O’Shaughnessy M, O’Malley VP, Corbett G, Given HF.
Optimum duration of surgical scrub-time. British Journal of Surgery 1991;78(6):685–6.
Olson 2012 {published data only} Olson LKM, Morse DJ, Duley C, Savell BK. Prospective, randomized in vivo comparison of a dual-active waterless antiseptic versus two alcohol-only waterless antiseptics for surgical hand antisepsis. American Journal of Infection Control 2012;40(2):155–159.
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Parienti 2004 {published data only} Parienti JJ, Du Cheyron D, Ramakers M, MAlbruny B, Leclerq R, Le Coutour X, et al. members of the NACRE Study Group. Alcoholic povidone-iodine to prevent central venous catheter colonization: a randomized unit-crossover study. Critical Care Medicine 2004;32(3):708–13.
Paulson 1994 {published data only} Paulson DS. Comparative evaluation of ve surgical hand scrub preparations. AORN Journal1994;60(2):246–6.
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American Journal of Infection Control 1999;27(4):332–8. Peterson 1978 {published data only} Peterson AF, Rosenberg A, Alatary SD. Comparative evaluation of surgical scrub preparations. Surgery, Gynecology and Obstetrics 1978;146(1):63–5.
Phimolsarnti 1986 {published data only} Phimolsarnti R, Kongsamrarn S, Limwongse K, Jitniyom P, Vutavipart P. Effectiveness of surgical hand scrub solutions.
Southeast Asian Journal of Surgery 1986;9(1):96–100.
Poon 1998 {published data only} Poon C, Morgan DJ, Pond K, Kane J, Tulloh B. Studies of the surgical scrub. Australian and New Zealand Journal of Surgery 1998;68(1):65–7.
Rehork 1991 {published data only} Rehork B, Ruden H. Investigations into the ef cacy of different procedures for surgical hand disinfection between consecutive operations. Journal of Hospital Infection 1991; 19 (2):115–27.
Reid 1991 {published data only} Reid AB, Stranc MF. Healing of infected wounds following iodine scrub or CO 2laser treatment.
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Rotter 1980 {published data only} Rotter ML, Koller W, Wewalka G. Povidone iodine and chlorhexidine gluconate containing detergents for disinfection of the hands. Journal of Hospital Infection 1980; 1 (2):149–58.
Rotter 1984 {published data only} Rotter ML. Hygienic hand disinfection. Infection Control 1984; 5(1):18–22.
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Rotter 1998 {published data only} Rotter ML, Simpson RA, Koller W. Surgical hand disinfection with alcohols at various concentrations.
Infection Control and Hospital Epidemiology 1998;19:
778–81.
Rotter 2005 {published data only} Rotter M, Satter SA, Dharan S, Webber P, Voss A, Pittet D. Comparative ef cacy of hand hygiene agents in the reduction of bacteria and viruses. American Journal of Infection Control 2005;339:558–60.
Rotter 2006 {published data only} Rotter M, Kundi M, Suchomel M, Karke HP, Kramer A, Ostermeyer C, et al. Reproducibility and workability of the European test standard EN 12791 regarding the effectiveness of surgical hand antisepsis: a randomised, multicentre trial.
Infection Control and Hospital Epidemiology 2006;27:935–9. 29 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Sattar 2000{published data only} Sattar AB, Abebe M, Jampani H, Newman J, Hua S. Activity of an alcohol based hand gel against human adeno-rhino- and rotaviruses using the nger pad method. Infection Control and Hospital Epidemiology 2000;21(8):516–9.
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Scott 1991 {published data only} Scott D, Barnes A, Lister M, Arkell P. An evaluation of the user acceptability of chlorhexidine handwash formulations.
Journal of Hospital Infection 1991;18(Suppl B):51–5.
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Simor 2007 {published data only} Simor AE, Phillips E, McGeer A, Konvalinka A, Loeb M, Devlin HR, et al. Ramdomized controlled trial of chlorhexidine gluconate for washing, intranasal mupirocin, and rifampin and doxycycline versus no treatment for the eradication of methicillin-resistant Staphylococcus aureu s colonization. Clinical Infectious Diseases 2007;44(2):
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Springer 2002 {published data only} Springer R. To brush or not to brush. Plastic Surgery Nursing 2002;22(4):185–8.
Stahl 2007 {published data only} Stahl JB, Morse D, Parks PJ. Resistance of antimicrobial skin preparations to saline rinse using a seeded bacteria model. American Journal of Infection Control 2007;35(6):
367–73.
Starr 2005 {published data only} Starr RV, Zurawaski J, Ismail M. Preoperative vaginal preparations with povidone iodine and the risk of postcesarean endometritis. Obstetrics and Gynecology2005; 105 (5 Pt1):1024–9.
Stevenson 2003 {published data only} Stevenson J, McNaughton G, Riley J. The use of prophylactic ucloxacillin in treatment of open fractures of the distal phalanx within an accident and emergency department. Journal of Hand Surgery 2003;28B(5):388–94. Sullivan 2008 {published data only} Sullivan PJ, Healy CE, Hirpara KM, Hussey AJ, Potter SM, Kelly JL. An assessment of skin preparation in upper limb surgery. Journal of Hand Surgery: European Volume 2008;33 (4):513–4.
Tanner 2008 {published data only} Tanner J. Surgical hand antisepsis: the evidence. Journal of Periopertive Practice 2008;18(8):339.
Thiele 2008 {published data only} Thiele RH, Huffmyer JL, Nemergut EC. The “six stigma approach” to the operating room environment and infection. Best Practice and Research: Clinical Anaesthesiology 2008; 22(3):537–52.
Tucci 1977 {published data only} Tucci V, Stone AM, Thompson C. Studies of the surgical scrub. Surgery, Gynecology and Obstetrics 1977;145:415–6.
Valente 2003 {published data only} Valente JH, Forti RJ, Freundlich LF, Zandieh SO, Crain EF.
Wound irrigation in children:saline solution or tap water?.
Annals of Emergency Medicine 2003;41(5):609–16.
Vogt 2006 {published data only} Vogt PM, Remier K, Hauser J, Rossbach O, Steinau HU, Bosse B, et al. PVP-iodine in hydrosomes and hydrogel - a novel concept in wound therapy leads to enhanced epithelialization and reduced loss of skin grafts.. Burns 2006; 32(6):698–705.
Voss 1997 {published data only} Voss A, Widmer AF. No time for handwashing?
Handwashing versus alcoholic rub: can we afford 100% compliance?. Infection Control and Hospital Epidemiology 1997; 18(3):205–8.
Vossinakis 2004 {published data only} Vossinakis IC, Stavroulaki P, Paleochorlidis, Badras LS.
Reducing the pain associated with local anaesthetic in ltration for open carpal tunnel decompression. Journal of hand surgery 2004;29(4):399–401.
Walwaikar 2002 {published data only} Walwaikar PP, Morye VK, Gawde AS. Open, prospective trial to evaluate the ef cacy and safety of combination of metronidazole and povidone iodine in comparison to povidone iodine alone in pre- and post sterilisation and surgical wound healing. Journal of the Indian Medical Association 2002;100(10):615–8.
Waterman 2006 {published data only} Waterman TR, Smeak DD, Kowalski J, Hade EM.
Comparison of bacterial counts in glove juice of surgeons wearing smooth band rings versus those without rings.
American Journal of Infection Control 2006;34(7):421–5.
Webster 1989 {published data only} Webster J, Faoagali JL. An in-use comparison of chlorhexidine gluconate 4% w/v. glycol-poly-siloxane plus methylcellulose and a liquid soap in a special care baby unit.
Journal of Hospital Infection 1989;14(2):141–51. 30 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Wernze 1975{published data only} Wernze H, HIlfenhaus M, Rietbrock I, Schuttke R, Kuhn K. Plasma renin activity and plasma aldosterone during anaesthesia and operative stress and beta-adrenergic blockade. Anaesthesist 1975;24(11):476–6.
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Yeung 2007 {published data only} Yeung JWK, Tam WWS, Wong T-W. A review of the evidence for hand hygiene in different clinical and community settings for family physicians. Hong Kong Practitioner 2007;29(4):157–63.
Yuldashkhan 2008 {published data only} Yuldashkhan M, Bolurchifard F, Amiri Z. Comparing two antiseptic solutions for scrubbing “decosept with povidone iodine” [Original article in Farsi]. SBMU Faculty of Nursing and Midwifery Quarterly 2008;18(60):14–20.
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Handwashing with soap or alcoholic solutions? A randomised clinical trial of its effectiveness. American Journal on Infection Control 1999;27:258–61.
References to studies awaiting assessment Chen 2012 {published and unpublished data} Chen CF, Han CL, Kan CP, Chen SG, Hung PW. Effect of surgical site infections with waterless and traditional hand scrubbing protocols on bacterial growth. American Journal of Infection Control 2012;40(4):e15–e17.
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References to other published versions of this review Tanner 2003 Swarbrook S, Stuart J, Tanner J. Surgical hand antisepsis to reduce surgical site infection (Protocol). Cochrane Database of Systematic Reviews 2003, Issue 2. [DOI: 10.1002/ 14651858.CD004288] Tanner 2008 Tanner J, Swarbrook S, Stuart J. Surgical hand antisepsis to reduce surgical site infection. Cochrane Database of Systematic Reviews 2008, Issue 1. [DOI: 10.1002/ 14651858.CD004288.pub2] Indicates the major publication for the study 32 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. C H A R A C T E R I S T I C S O F S T U D I E S Characteristics of included studies[ordered by study ID] Al-Naami 2009 Methods Randomised controlled trial (described as an equivalence study ) Generation of random number sequence: no details given Allocation concealment: no details given Blinding: blinding of outcome assessors; no other details gi ven A priori sample calculations: yes Antisepsis protocol: yes (partial) Withdrawals: incomplete details given Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 1 hospital General Surgery division; surgeons (no further in formation on personnel) 600 patients initially randomised from general surgery; da ta reported on 500 General Surgery: abdominal (e.g. cholecystectomy) and other; m ixture of clean and clean-contaminated operations Interventions Group 1 - traditional surgeons’ handscrub for 3-5 min using 7.5 % povidone iodine (Betadine) or 4% chlorhexidine gluconate (Hibiscrub) (228 patien ts) Group 2 - As with group 1 for rst case; subsequent antisepsis w ith alcohol handrub with 62% ethanol (Purrel) 10 ml, allowed to dry (272 patients) Outcomes Surgical site infection de ned as any one or more of the followi ng: symptoms and signs (pain, swelling, redness, hotness, tenderness, induration s, purulent discharge, opened wound) occurring within 30 d from surgery (examinations before discharge, at 1 week, at 1 month, and C/S results); no further detail supplied Notes All patients had standardised skin preparation. 76% of pati ents had prophylactic antibi- otics (indicated for speci ed surgeries); no difference between a rms Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk No information on sequence generation Quote: “Participants were randomised to either a routine hand scrub or an alcohol hand-rub upon selecting a sealed envelope for each case.” No further information Allocation concealment (selection bias) Unclear risk No further information; not clear if en- velopes were opaque or sequentially num- bered 33 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Al-Naami 2009(Continued) Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk Clear differences between the procedures employed mean blinding of participants was not possible Blinding (performance bias and detection bias)All outcomes - Blinding care givers Unclear risk No information reported Blinding (performance bias and detection bias)All outcomes - Blinding outcome assessors Low risk Assessment of wound appearance and swab by personnel unaware of allocation Quote: “Surgeons who examined surgical sites were unaware of the groups’ alloca- tion”; “A swab was sent for C/S from any suspected SSI. Health care personnel tak- ing swabs and interpreting results of C/S were also unaware of how hand disinfec- tion for each group had been allocated.” Incomplete outcome data (attrition bias) All outcomes High risk 100 (1 in 6) participants originally ran- domised were excluded from analysis. The reasons for this are not fully explored Quote: “Initially an equal number of cases (300 patients in each group) were ran- domised to each method. However, more cases were further excluded from each group as they turned out to be non-eligi- ble for inclusion after the original random- ization (e.g. acute or chronic cholecystitis on histopathological examination), incom- plete forms, failed follow-ups, etc.” Selective reporting (reporting bias) Low risk Authors reported all speci ed objectives.
Quote: “The objective of this study is to de- termine the equal ef cacy of alcohol-based hand-rub as compared to traditional sur- gical scrub in the prevention of SSI as the primary outcome measure; the compliance of surgical staff and skin tolerance as the secondary outcome measure; also keeping in mind cost effectiveness and the potential change in surgical practice at least in our institution” Other bias Low risk No other sources of bias detected 34 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Furukawa 2005 Methods Randomised controlled trialGeneration of random number sequence: no details given Allocation concealment: no details given Blinding: no details given A priori sample calculations: no Antisepsis protocol: yes Withdrawals: no details given Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 22 operating room nursesBaseline comparability: baseline bacterial counts Interventions Group 1 - 3 min scrub using aqueous chlorhexidine gluconateGroup 2 - 3 min scrub using aqueous povidone iodine Outcomes Outcome measure: CFUs on participants’ hands Method of testing: glove juice method Timing of testing: before antisepsis and after antisepsis (n o information regarding how long after antisepsis testing was conducted) Notes Participants did not take part in any surgical procedures Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Quote: “Twenty-two operating room nurses were randomly divided into two groups as follows: the PVI group (n = 11) and the CHG group (n = 11). All the nurses were examined for bacterial contam- ination of their hands before and after sur- gical handwashing” Comment: Evidence of randomisation, however not enough evidence to suggest truly randomised sequence generation Allocation concealment (selection bias) Unclear risk Quote: “Twenty-two operating room nurses were randomly divided into two groups as follows: the PVI group (n = 11) and the CHG group (n = 11). All the nurses were examined for bacterial contam- ination of their hands before and after sur- gical handwashing” Comment: No evidence that appropriate allocation concealment took place 35 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Furukawa 2005(Continued) Blinding (performance bias and detection bias) All outcomes - Blinding participants Unclear risk Quote: “All the nurses were examined for bacterial contamination of their hands be- fore and after surgical handwashing” Comment: No evidence of blinding of par- ticipants or personnel to blinding to inter- vention Blinding (performance bias and detection bias) All outcomes - Blinding care givers Unclear risk Quote: “All the nurses were examined for bacterial contamination of their hands be- fore and after surgical handwashing” Comment: No evidence of blinding of par- ticipants or personnel to blinding to inter- vention Blinding (performance bias and detection bias) All outcomes - Blinding outcome assessors Unclear risk Tap water outcome Quote: “We took water samples from 4 faucets just before hand washing and 1 ml of each sample was injected onto Brain- Heart infusion bouillon plats (Eiken K. K) and cultured at 37 Celsius for 48 hours for bacterial detection.” Comment: Samples seemingly taken by personnel, however unclear as to the role bias would play in the quantitative study of bacterial colonies in water faucets Hands and ngers outcome Quote: “The samples were collected and pre-treated according to the Glove Juice method. In detail, the sample liquid was taken from the right glove just before hand washing and from the left glove after hand washing”. This was then “cultured at 37 Celcius for 48 hours, thereafter the num- ber of bacterial colonies was counted” Comment: Unclear as to whether those ob- taining the samples were blinded to the in- tervention. It is likely that they were not blinded; however the overall judgement is unclear Incomplete outcome data (attrition bias) All outcomes Low risk No direct quotes, however no losses to fol- low-up encountered Comment: Low risk of attrition bias. Selective reporting (reporting bias) Low risk Quote: no direct quotes.
Comment: Both outcome assessments of 36 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Furukawa 2005(Continued) bacterial contamination of tap water and hands and ngers before and after surgical handwashing were accounted for in the re- sults Other bias Low risk No other sources of bias detected Gupta 2007 Methods Randomised cross-over controlled trial Generation of random number sequence: no details given Allocation concealment: no details given Blinding: not possible to blind participants A priori sample calculations: yes Antisepsis protocol: no Withdrawals: 2 Intention-to-treat analysis: no Clear inclusion or exclusion criteria: yes Participants 18 operating room staff working in ophthalmic, podiatric and general surgery Baseline comparability: baseline bacterial counts Interventions Group 1 - brush application of 7.5% povidone iodine aqueous scr ub Group 2 - three 2 ml application of 1% chlorhexidine gluconate in 61% ethyl alcohol Group 3 - 3 min application of zinc pyrithione in 70% ethyl alcoh ol and rinsed with water Outcomes Outcome measure: CFUs on participants’ hands Method of testing: glove juice method Timing of testing: before antisepsis and immediately after antisepsis on day 1, after 6 hours on days 2 and 5 Notes - Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Quote: Participants “were assigned to at random to one of three groups. Each group used one of the three solutions for ve con- secutive days. The following week, each group used a different scrub solution, such that all participants used each product over the study duration” Comment: Unclear as to whether a random sequence generator was used 37 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Gupta 2007(Continued) Allocation concealment (selection bias) Unclear risk Quote: Participants “were assigned to at random to one of three groups. Each group used one of the three solutions for ve con- secutive days. The following week, each group used a different scrub solution, such that all participants used each product over the study duration” Comment: Unclear as to whether alloca- tion was concealed. Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk Quote: “Participants could not be blinded to the three solutions due to differences in their nature and method of application” Comment: Study describes that blinding of participants was not possible.There is no information given as to whether the inves- tigators were blinded, but it is likely there were similarly unblinded to the interven- tion for the reasons given for the partici- pants above. The judgement for participant blinding is therefore high risk Blinding (performance bias and detection bias)All outcomes - Blinding care givers Unclear risk Quote: “Participants could not be blinded to the three solutions due to differences in their nature and method of application” Comment: Study describes that blinding of participants was not possible.There is no information given as to whether the inves- tigators were blinded, but it is likely there were similarly unblinded to the interven- tion for the reasons given for the partici- pants above. The judgement for blinding of caregivers here is unclear Blinding (performance bias and detection bias)All outcomes - Blinding outcome assessors Unclear risk Bacterial sampling Quote: “The subject introduced their hands into this bag and the investigator massaged their hands externally with em- phasis on web spaces and subungual areas” Comment: no attempt made at blind- ing method of obtaining bacterial sample, which would advise a high risk of bias de- cision Microbial assay Quote: “Samples were sent to the microbi- ology laboratory immediately after collec- tion in a blinded manner” 38 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Gupta 2007(Continued) Comment: There was adequate evi- dence that approach microbial testing was blinded Therefore, overall assessment of the risk of bias for outcome assessment is unclear Incomplete outcome data (attrition bias) All outcomes Low risk Quote: “Eighteen surgical staff members participated in this study. All members used each of the three scrub solutions over the duration or the study . . . Two volunteers developed a skin rash and a burning sensa- tion on their hands within and a few min- utes after their rst scrub with the ABWA product. They also reported a metallic taste in their mouth and palpitations. Although none of their symptoms were severe and re- solved shortly thereafter without any med- ical intervention, they were removed from the study. All the remaining staff volunteers completed the study” Comment: small loss to follow-up and full explanations given as to the reasons for dropout Selective reporting (reporting bias) Low risk No direct quotes, although the ef cacy of the product in terms of reduction of log reduction in bacterial counts and prod- uct preference by participants are both in- cluded in the Results in full and compre- hensive manner, as outlined in the Meth- ods Other bias Unclear risk Cross-over design, unclear if accounted for in analysis Hajipour 2006 Methods Cluster randomised controlled trialGeneration of random number sequence: random number table Allocation concealment: no details given Blinding: microbiologist was blinded A priori sample calculations: no Antisepsis protocol: yes Withdrawals: no details given Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no 39 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Hajipour 2006(Continued) Participants 4 surgeons working in a trauma surgery Baseline comparability: surgeon’s grade, order of patient o n the operating list, duration of surgery Interventions Group 1 - 3 min scrub using aqueous chlorhexidine gluconate Group 2 - 3 min application of 0.5% chlorhexidine gluconate in 70 % alcohol All surgeons washed with chlorhexidine (no further detail) fo r 5 min for rst procedure with thorough cleaning under ngernails Outcomes Outcome measure: CFUs on participants’ hands Method of testing: nger press testing with agar plates Timing of testing: at the end of the surgical procedure Notes The 4 surgeons, who were not blinded, were randomised once and tested 53 times Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk Quote: “Orthopaedic surgeons were allo- cated to one of two different hand-washing protocols using a randomisation table” Comment: evidence of random sequence generation, therefore judged as low risk Allocation concealment (selection bias) Unclear risk Quote: “[T]he surgeon was randomised to wash for 5 min with either chlorhexidine or alcohol gel” Comment: no evidence that there was an attempt at allocation concealment Blinding (performance bias and detection bias) All outcomes - Blinding participants Unclear risk Quote: “The hand-washing protocol dic- tated that all surgeons should wash for 5 min with chlorhexidine for their rst case with thorough cleaning under the n- gernails. Thereafter, the surgeon was ran- domised to wash for 5 min with either the chlorhexidine or alcohol gel. Alcohol was allowed to dry on the hands prior to double gloving” Comment: no evidence that participants or personnel were blinded to intervention 40 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Hajipour 2006(Continued) Blinding (performance bias and detection bias) All outcomes - Blinding care givers Unclear risk Quote: “The hand-washing protocol dic- tated that all surgeons should wash for 5 min with chlorhexidine for their rst case with thorough cleaning under the n- gernails. Thereafter, the surgeon was ran- domised to wash for 5 min with either the chlorhexidine or alcohol gel. Alcohol was allowed to dry on the hands prior to double gloving” Comment: no evidence that participants or personnel were blinded to intervention Blinding (performance bias and detection bias) All outcomes - Blinding outcome assessors Low risk Quote: “The number of bacterial colonies present after 24 h and 48 h of incubation were recorded for each agar plate by a mi- crobiologist blinded to the washing proto- col used” Comment: adequate blinding of assess- ment outcome Incomplete outcome data (attrition bias)All outcomes Low risk Quote: “Overall, 41 procedures and 82 episodes of handwashings were included in the study. Two episodes were discarded due to contamination at the time of glove re- moval. There was no incidence of outer glove perforation during this study” Comment: good evidence to suggest losses to follow-up were accounted for and there was minimal effect of attrition bias Selective reporting (reporting bias) Low risk No direct quotes, but the assessment vari- able of bacterial colonisation after different methods of handwashing (which was out- lined in the methodology) is accounted for in the results Other bias Unclear risk This appears to be a clustered randomised trial; it does not seem that clustering was taken into account in the analysis 41 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Herruzo 2000 Methods Randomised cross-over controlled trialGeneration of random number sequence: no details given Allocation concealment: no details given Blinding: no details given A priori sample calculations: no Antisepsis protocol: minimal details Withdrawals: no details given Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 154 members of the surgical teams working in plastic surgery a nd traumatology Baseline comparability: baseline bacterial counts Interventions Group 1 - 3 min scrub using aqueous chlorhexidine gluconate, n = 5 0 Group 2 - 3 min scrub using aqueous povidone iodine, n = 49 Group 3 - 3 min rub with N-duopropenide, n = 55 Outcomes Outcome measure: CFUs on participants’ hands Method of testing: nger press testing with agar plates Timing of testing: before antisepsis, immediately after an tisepsis and at the end of the surgical procedure Notes - Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Quote: “Healthy volunteers washed with one of the three products for 1 week for 3 consecutive weeks. The order of the wash- ings was randomised” Comment: indication that a randomisation process was undertaken, however not clear how the sequence was generated Allocation concealment (selection bias) Unclear risk Quote: “Healthy volunteers washed with one of the three products for 1 week for 3 consecutive weeks. The order of the wash- ings was randomised” Comment: no evidence of allocation con- cealment given Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk Quote: “The effect of standard surgical washings with 7.5% iodine povidone or 4% chlorhexidine (both with scrubbing for 3 min following a standard technique) was compared with the effect of washing (with- out scrubbing with 2.3% N-duopropenide 42 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Herruzo 2000(Continued) in 60 ispopropranol with dermoprotec- tive substance). The latter solution was poured over the hands, which were then rubbed together, and when it began to dry, it was reapplied over 3 min.” Comment: The study design here is a cross- over design, reducing potential effects of bias; however, there is no evidence that par- ticipants or personnel were blinded to the intervention given, and the conditions dif- fered suf ciently that blinding would not have been possible Blinding (performance bias and detection bias) All outcomes - Blinding care givers High risk Quote: “The effect of standard surgical washings with 7.5% iodine povidone or 4% chlorhexidine (both with scrubbing for 3 min following a standard technique) was compared with the effect of washing (with- out scrubbing with 2.3% N -duopropenide in 60 isopropanol with dermoprotective substance. The latter solution was poured over the hands, which were then rubbed together, and when it began to dry, it was reapplied over 3 min.” Comment: The study design here is a cross- over design, reducing potential effects of bias; however, there is no evidence that par- ticipants or personnel were blinded to the intervention given, and the conditions dif- fered suf ciently that blinding would not have been possible Blinding (performance bias and detection bias) All outcomes - Blinding outcome assessors Unclear risk Quote: “We used ngertips to sample hand bacteria as the standard European Norm (pr EN 1500) except we had not arti cially contaminated the hands: ve ngertips are rubbed for 1 min on a Petri dish containing 10 ml of TBS plus an antiseptic neutral- ize ”. These were cultured for “48 h at 37 C, and the then the CFU/hand (the ve ngertips), were counted and transformed into a decimal logarithm” Comment: Despite the assessment being quantitative, it is not clear whether those who obtained the bacterial samples were in- dependent of the study or blinded to the intervention 43 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Herruzo 2000(Continued) Incomplete outcome data (attrition bias) All outcomes Low risk No direct quotes, although no losses to fol- low-up recorded in Results Comment: no obvious source of attrition bias Selective reporting (reporting bias) Low risk No direct quotes Comment: tabular format of results incor- porates the assessment outcomes outlined (CFUs) between the groups, suggesting a low risk Other bias Unclear risk Although the trial had a cross-over design, it did not appear that this was re ected in the analysis Kappstein 1993 Methods Randomised cross-over trial (participants took part in each of 3 g roups) Generation of random number sequence: no details given Allocation concealment: no details given Blinding: no details given A priori sample calculations: yes Antisepsis protocol: no Withdrawals: no details given Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 24 surgeons Baseline comparability: baseline bacterial counts Interventions Group 1 - 1 min wash with soap and water followed by 5 min rub wit h an alcoholic disinfectant Group 2 - 1 min wash with soap and water followed by 3 min rub wit h an alcoholic disinfectant Group 3 - 1 min was with chlorhexidine soap followed by two min o f rubbing with 0.
5% chlorhexidine in isopropanol Outcomes Outcome measure: CFUs on participants’ hands Method of testing: glove juice method Timing of testing: before antisepsis and immediately after antisepsis Notes - Risk of bias Bias Authors’ judgement Support for judgement 44 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Kappstein 1993(Continued) Random sequence generation (selection bias) Unclear risk Just states “random order” with no further information Allocation concealment (selection bias) Unclear risk As with sequence generation; no further in- formation Blinding (performance bias and detection bias) All outcomes - Blinding participants Unclear risk Standard technique compared with shorter techniques precludes blinding of personnel but no further information Blinding (performance bias and detection bias)All outcomes - Blinding care givers Unclear risk Standard technique compared with shorter techniques precludes blinding of personnel but no further information Blinding (performance bias and detection bias)All outcomes - Blinding outcome assessors Unclear risk No information on blinding of assessment reported Incomplete outcome data (attrition bias)All outcomes Low risk No evidence of dropouts/loss of data Selective reporting (reporting bias) Low risk All speci ed outcomes reported Other bias Unclear risk Although the trial had a cross-over design, it did not appear that this was re ected in the analysis Nthumba 2010 Methods Cluster-randomised controlled cross-over trial Generation of random number sequence: appropriateAllocation concealment: no details given but considered unlike ly to be an issue in cluster- randomisation Blinding: outcome assessors A priori sample calculations: yes Antisepsis protocol: yes Withdrawals: details of patients without postdischarge sur veillance Intention-to-treat analysis: no Clear inclusion or exclusion criteria: yes Participants 66 surgeons and trainees; 3317 patients Interventions Group 1 - plain soap and water: 4-5 min clean running water and pl ain soap; sterile cotton hand towel dry. 5 clusters (n = 1682 patients) Group 2 - As group 1 before rst procedure of day and subsequent ly in case of visible soiling, then alcohol-based handrub (75% isopropyl alcohol, 1. 45% glycerol, 0.125% hydrogen peroxide) for 3 min and kept wet (7-10 ml per preparati on) 45 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Nthumba 2010(Continued) Outcomes SSI (de ned using modi ed US Centers for Disease Control and P revention de nitions for nosocomial infection) detected by tours of hospital wards; reviews in outpatient clinic; telephone contact: diagnosis established jointly by study col laborators Notes - Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk Surgical hand preparation procedures were assigned randomly to the 6 participating operating theatres by tossing a coin, with a cross-over every 2 months. There was no indication of baseline imbalance for impor- tant variables such as type of surgery, con- tamination level of the surgery or use of an- tibiotic prophylaxis Allocation concealment (selection bias) Low risk Allocation was decided by toss of a coin.
Not clear who undertook this process and if it was concealed from the sites. Given that this was a cluster trial with cross-over, the potential for bias stemming from allocation concealment was limited. As the Cochrane Handbook for Systematic Reviews of Inter- ventionsnotes, “Cluster-randomised trials often randomise all clusters at once, so lack of concealment of an allocation sequence should not usually be an issue.” Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk Personnel were aware of allocation as pro- cedures differed in obvious ways Compliance by surgical teams was de- termined by observation of practices. A trained observer who did not belong to the surgical team checked whether each sink had the correct hand preparation and whether all surgeons (including visiting staff ) followed the recommended hand preparation procedures Blinding (performance bias and detection bias)All outcomes - Blinding care givers Unclear risk No information reported Blinding (performance bias and detection bias) Low risk Diagnosis, documentation and determina- tion of SSI by personnel without knowl- 46 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Nthumba 2010(Continued) All outcomes - Blinding outcome assessors edge of allocation “SSI was diagnosed . . . and documented by a trained nurse who visited the surgical wards three to four times each week dur- ing the 30 days after surgery. Patients dis- charged before this were reviewed in the outpatient clinic or contacted by telephone . . . The nurse was blinded to the method of surgical hand preparation. The diagnosis of SSI was established jointly by the study collaborators; differences in SSI ascertain- ment were resolved by consensus without knowledge of the study allocation of the patient.” Incomplete outcome data (attrition bias) All outcomes Low risk 3722 patients underwent a surgical pro- cedure in the operating theatre, and 3317 were included in the 10 study clusters. Post- discharge surveillance data could not be ob- tained for 184 patients (5.5%) Selective reporting (reporting bias) Low risk The primary objective of this cluster-ran- domised, cross-over trial was to compare the ef cacy of plain soap and water with alcohol-based handrub, using SSI rates as the main outcome measure. The feasibility and affordability of the local production of an alcohol-based handrub was also investi- gated, together with an assessment of its ac- ceptability among healthcare workers. All speci ed outcomes were reported Other bias Low risk There was no evidence of other sources of bias. Clustered nature of the data was taken into account in the trial 47 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Parienti 2002 Methods Cluster-randomised controlled equivalence trialGeneration of random number sequence: random number tables Allocation concealment: no details given Blinding: discussed but only conducted during postdischarge fo llow-up A priori sample calculations: yes Antisepsis protocol: yes Withdrawals: 51 patients lost during follow-up Intention-to-treat analysis: yes Clear inclusion or exclusion criteria: yes Participants Surgical teams within 6 hospitals were randomised. 4387 pati ents undergoing clean and clean-contaminated surgery were included in the study. Baseline comparability: details of surgical procedures, dura tion of surgery, patients’ ASA classi cations Interventions Group 1 - 5 min scrub using either 4% povidone iodine or 4% chlorh exidine gluconate Group 2 - 5 min handrub with alcohol solution containing 75% pro panol-1, propanol -2 with mecetronium ethylsulphate Outcomes Outcome measure: SSIs in patients at 30 d using CDC de nition Method of testing: observation by surgeon or infectious dise ase specialist, case note review, telephone interview Timing of testing: 30 d follow-up Notes Unclear if clustering is adjusted for in the analysis Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk Quote: “Each participating surgical service was assigned a 2-digit random number by using a random number table. Surgical ser- vices corresponding to the 3 higher num- bers were assigned to hand-rubbing with AAS and the remaining 3 services were as- signed to traditional hand-scrubbing” Comment: adequate evidence of random sequence generation Allocation concealment (selection bias) Unclear risk Quote: “Each participating surgical service was assigned a 2-digit random number by using a random number table. Surgical ser- vices corresponding to the 3 higher num- bers were assigned to handrubbing with AAS and the remaining 3 services were as- signed to traditional hand-scrubbing” Comment: no evidence of allocation con- cealment 48 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Parienti 2002(Continued) Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk Quote: “[O]bservers of the clinical out- come could not be blinded to the hand an- tisepsis protocol.” The study also mentions that “compliance observers did not belong to the operating department team but were usually present in the surgical suite. To avoid a Hawthorne effect the surgical teams were not informed of the timing of the eval- uations” Comment: Although the effect of blinding has been considered, in the comparison of different scrubbing protocols it would be dif cult to blind the participant or person- nel. The risk of bias is still high in this in- stance, however Blinding (performance bias and detection bias) All outcomes - Blinding care givers High risk Quote: “[O]bservers of the clinical out- come could not be blinded to the hand an- tisepsis protocol.” The study also mentions that “compliance observers did not belong to the operating department team but were usually present in the surgical suite. To avoid a Hawthorne effect the surgical teams were not informed of the timing of the eval- uations” Comment: Although the effect of blinding has been considered, in the comparison of different scrubbing protocols it would be dif cult to blind the participant or person- nel. The risk of bias is still high in this in- stance, however Blinding (performance bias and detection bias)All outcomes - Blinding outcome assessors High risk Surgical site infection outcome Quote: “According to CDC guidelines, all SSIs had to be con rmed by the surgeon or the physician in charge on the patient.
Thus, observers of the clinical outcome could not be blinded to the hand antisepsis protocol” Comment: As the surgeon was the partici- pant in this case. it is clear that this could constitute a high risk of bias Tolerance and compliance outcome Quote: “[T]he surgical personnel (77 sub- jects) were asked to estimate the effect of the 2 protocols on their skin. We used 2 10 cm visual analogue scales, at month 0 and af- ter 3 crossovers; 0 cm representing absence 49 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Parienti 2002(Continued) of an tolerance problem and 10 cm rep- resenting maximal dryness with chapped hands and desquamation or maximal irri- tation with erythema, burning sensation, and abrasion.” Comment: The surgeon was the (un- blinded) participant who reported the vari- ables, so the results may be affected by per- formance bias Incomplete outcome data (attrition bias) All outcomes Low risk Quote: “During the study period . . . 4823 consecutive patients underwent surgery.
Among these, 385 patients underwent con- taminated or dirty-contaminated surgery, and 51 were lost to follow up at 30 days (17 in the hand-rubbing group). The re- maining 4387 patients (68.5% of whom underwent clean surgery) were considered for analysis” Comment: As the sample size is large, the numbers lost to follow-up are not signi - cant enough to warrant a risk of attrition bias Selective reporting (reporting bias) Low risk Quote: “Thirty-day surgical site infections rates were the primary end point; oper- ating department teams’ tolerance of and compliance with hand antisepsis were sec- ondary end points” Comment: adequate evidence in the results that these endpoints were accounted for comprehensively Other bias Unclear risk This appears to be a clustered cross-over study; it does not seem that clustering was taken into account in the analysis 50 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pereira 1990 Methods Randomised controlled cross-over trial (Latin square design - participants took part in each of 4 interventions) Generation of random number sequence: no details given Allocation concealment: no details given Blinding: no details given A priori sample calculations: no Antisepsis protocol: yes Withdrawals: 2 participants withdrew Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 34 anaesthetic, recovery and ward nursesBaseline comparability: gender, age, ethnicity, hand domina nce, baseline bacterial counts Interventions Group 1 - 5 min initial scrub and 3 min subsequent scrub using chlo rhexidine Group 2 - 3 min initial and 30 s subsequent scrub using chlorhexi dine Group 3 - 5 min initial and 3 min subsequent scrub using povidon e iodine Group 4 - 3 min initial and 30 s subsequent scrub using povidone iodine Outcomes Outcome measure: CFUs on participants’ hands Method of testing: glove juice method Timing of testing: before antisepsis, immediately after an tisepsis, 2 h after initial anti- sepsis, 2 h after subsequent antisepsis Notes Participants did not take part in any surgical procedures Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Quote: “Subjects were randomly assigned to one of four groups, and each group was assigned to one of the four scrub regimens each week. Control on the treatment order was achieved through a Latin square design, as described by Winder.” Comment: adequate evidence of an appro- priate study design, but on balance not enough evidence of truly random sequence generation Allocation concealment (selection bias) Unclear risk Quote: “Subjects were randomly assigned to one of four groups, and each group was assigned to one of the four scrub regimens each week. Control on the treatment order was achieved through a Latin square design, as described by Winder.” Comment: no indication that allocation to 51 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pereira 1990(Continued) each group was concealed to the personnel Blinding (performance bias and detection bias) All outcomes - Blinding participants Unclear risk Quote: “Subjects were randomly assigned to one of four groups, and each group was assigned to one of the four scrub regimens each week . . . Subjects were supervised by the investigator while they scrubbed on all test occasions.” Comment: no evidence to suggest that there was appropriate blinding of partici- pants or personnel during the study Blinding (performance bias and detection bias) All outcomes - Blinding care givers Unclear risk Quote: “Subjects were randomly assigned to one of four groups, and each group was assigned to one of the four scrub regimens each week . . . Subjects were supervised by the investigator while they scrubbed on all test occasions.” Comment: no evidence to suggest that there was appropriate blinding of partici- pants or personnel during the study Blinding (performance bias and detection bias)All outcomes - Blinding outcome assessors Unclear risk Bacterial contamination Quote: “While the glove was still on the hand, a sample of the uid was taken . . .
[S]amples were collected on four occasions for each condition: (1) immediately before scrubbing (both hands), (2) immediately after the initial surgical scrub (non-domi- nant hand only) (3) 2 hours after the initial surgical scrub, immediately before the con- secutive scrub (dominant hand) and (4) 2 hours after one consecutive surgical scrub (dominant hand).” Comment: no indication that those collect- ing the samples, administering the uid or those performing the microbial assays were in any way blinded to the intervention or protocol Incomplete outcome data (attrition bias)All outcomes Low risk Quote: “Thirty-six subjects were recruited, but two subjects withdrew from the experi- ment before completing all four treatments (scrubs) because of skin reactions, includ- ing erythema, burning sensations and local swelling” 52 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pereira 1990(Continued) Comment: adequate evidence that losses to follow-up were small and fully accounted for Selective reporting (reporting bias) Low risk No direct quotes, but the results of each ’scrub’ are displayed fully at baseline and subsequent time intervals in the Results as laid out in the Methodology Other bias Unclear risk Although the trial had a cross-over design, it did not appear that this was re ected in the analysis Pereira 1997 Methods Randomised controlled trial cross-over (Latin square design - p articipants took part in each of 5 interventions) Generation of random number sequence: no details given Allocation concealment: no details given Blinding: no details given A priori sample calculations: no Antisepsis protocol: yes Withdrawals: yes details provided Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 23 operating room nursesBaseline comparability: age, gender, skin condition, baseli ne bacterial counts Interventions Group 1 - 5 min initial and 3.5 min subsequent scrub using 4% chlo rhexidine Group 2 - 3 min initial and 2.5 min subsequent scrub using 4% chlo rhexidine Group 3 - 3 min initial and 2.5 min subsequent scrub using povid one iodine with triclosan Group 4 - 3 min initial scrub using 4% chlorhexidine followed by a 30 s application of isopropanol 70% and chlorhexidine 0.5%, and subsequent scrub s using 30 s application of isopropanol 70% and chlorhexidine 0.5% Group 5 - 2 min initial scrub using 4% chlorhexidine followed by a 30 s application of ethanol 70% and chlorhexidine 0.5%, and subsequent scrubs usi ng 30 s application of ethanol 70% and chlorhexidine 0.5% Outcomes Outcome measure: CFUs on participants’ hands Method of testing: glove juice method Timing of testing: before antisepsis, immediately after an tisepsis, 2 h after initial anti- sepsis, 2 h after subsequent antisepsis Notes Participants did not take part in any surgical procedures 53 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pereira 1997(Continued) Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Quote: “Subjects who agreed to participate in the study followed each of the scrub pro- tocols in turn, the order controlled by the use of a Latin square design. That is, every nurse was required to complete every pro- tocol but not in the same sequence.” Comment: clear that the study design does reduce selection bias; however not clear whether there is enough evidence to sug- gest random sequence was generated Allocation concealment (selection bias) Unclear risk Quote: “Subjects who agreed to participate in the study followed each of the scrub pro- tocols in turn, the order controlled by the use of a Latin square design. That is, every nurse was required to complete every pro- tocol but not in the same sequence.” Comment: no evidence to suggest that al- location was concealed to personnel Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk Quote: “Subjects who agreed to participate in the study . . . followed each scrub proto- col each day for one week (referred to as the ’test week’) with a week of normal activities between each test week. They were issued with a supply of the speci c antiseptic to be used in excess to their requirements for scrubbing so that the appropriate antisep- tic could be used exclusively during the test week. Subjects were assessed before com- mencing each scrub protocol and at the end of the test week to determine changes in the number of colony forming units (cfu) after scrubbing and changes in the condition of the hands.” Comment: Although study design allows for repeated testing, there is no evidence that there was effective blinding of partici- pants and personnel to the different inter- ventions, and differences between the con- ditions would have been clearly apparent to those taking part 54 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pereira 1997(Continued) Blinding (performance bias and detection bias) All outcomes - Blinding care givers High risk Quote: “Subjects who agreed to participate in the study . . . followed each scrub proto- col each day for one week (referred to as the ’test week)’ with a week of normal activities between each test week. They were issued with a supply of the speci c antiseptic to be used in excess to their requirements for scrubbing so that the appropriate antisep- tic could be used exclusively during the test week. Subjects were assessed before com- mencing each scrub protocol and at the end of the test week to determine changes in the number of colony forming units (cfu) after scrubbing and changes in the condition of the hands.” Comment: Although study design allows for repeated testing, there is no evidence that there was effective blinding of partici- pants and personnel to the different inter- ventions, and differences between the con- ditions would have been clearly apparent to those taking part Blinding (performance bias and detection bias) All outcomes - Blinding outcome assessors Unclear risk Sampling method Quote: “A glove juice sampling method to estimate the numbers of CFU present on the hands” Comment: no indication that those per- forming the sampling or performing the microbial assays were independent to the study Skin condition Quote: “Larson’s Weekly Skin Assessment Rating Scale was used to rate the condition of the hands with respect to appearance, integrity, moisture and sensation. Partici- pants rated themselves on a weekly basis.
An independent rater, blind to the proto- col being followed by the subject, also rated the subject’s dominant hand each week.” Comment: evidence that reasonable mea- sures were undertaken to blind outcome assessment. Overall assessment unclear for outcome assessment blinding Incomplete outcome data (attrition bias)All outcomes High risk Quote: “Of the 32 participants recruited, 23 completed all ve scrub protocols (scrubs) because it was discovered [that sev- 55 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pereira 1997(Continued) eral participants] were allergic or sensitive to one of the more antiseptics. One felt that her skin was already too dry to be able to participate further. One person could not complete the study because she was unex- pectedly off work for an extended period and the other two gave no reason for with- drawing.” Comment: fairly high rates of losses to fol- low-up and no information given as to why some participants did not complete the study. Although it seems that the re- searchers acted appropriately here, it is dif- cult to give a judgement other than high risk Selective reporting (reporting bias) Low risk No direct quotes, but reasonable evidence to suggest that both bacterial contamina- tion and skin condition have been appro- priately and fully tested and reported upon effectively Other bias Unclear risk Although the trial had a cross-over design, it did not appear that this was re ected in the analysis Pietsch 2001 Methods Randomised cross-over trial Generation of random number sequence: no details given Allocation concealment: no details given Blinding: no details given A priori sample calculations: no Antisepsis protocol: no Withdrawals: no details given Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 75 surgeonsBaseline comparability: baseline bacterial counts Interventions Group 1 - surgical scrub using 4% chlorhexidine (details of the du ration are not given) Group 2 - alcohol rub using Sterillium (45% w/w of propan-2-01, 30 % w/w of propan- l-01 and 0.2% w/w of ethylhexadecyldimethyl ammonium ethylsu lfate)(details of the duration are not given) Outcomes Outcome measure: CFUs on participants’ hands Method of testing: glove juice method Timing of testing: before antisepsis, immediately after an tisepsis and after surgical pro- 56 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pietsch 2001(Continued) cedure completed Notes - Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Dermal tolerance study Quote: “The rst study was performed with a panel of 60 volunteers divided in two sub- groups of 30 persons each.” Comment: no indication of how the sub- groups were divided Surgical hand disinfection study Quote: “In a randomised cross-over clinical trial the antimicrobial ef cacy of Sterillium for the surgical hand-rub was tested against Hibiscrub in the Kantonsspital Basel over a period of 11 weeks . . . two weeks were needed for recruitment, four weeks to con- duct the Sterillium arm of the study, one week’s interval and then four weeks for the Hibiscrub part.” Comment: no further information given as to how participants were recruited and how they were assigned and allocated to which intervention Hygienic hand disinfection study Quote: “The antimicrobial ef cacy of each product was compared with that of 60% (v/ v) 2-propanol on arti cially contaminated hands ( E. coliK 12, NCTC 10538) using a cross-over design with 15 volunteers.” Comment: no indication of if a randomised sequence was used and what method was implemented Allocation concealment (selection bias) Unclear risk Dermal tolerance Quote: “The rst study was performed with a panel of 60 volunteers divided in two sub- groups of 30 persons each” Comment: No indication of how allocation was concealed Surgical hand disinfection Quote: “In a randomised cross-over clinical trial the antimicrobial ef cacy of Sterillium for the surgical hand-rub was tested against Hibiscrub in the Kantonsspital Basel over 57 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pietsch 2001(Continued) a period of 11 weeks . . . two weeks were needed for recruitment, four weeks to con- duct the Sterilium arm of the study, one week’s interval and then four weeks for the Hibiscrub part.” Comment: no indication if allocation was concealed Hygienic hand disinfection Quote: “The antimicrobial ef cacy of each product was compared with that of 60% (v/ v) 2-propanol on arti cially contaminated hands ( E. coliK 12, NCTC 10538) using a cross-over design with 15 volunteers.” Comment: no Indication if allocation was concealed Blinding (performance bias and detection bias) All outcomes - Blinding participants Unclear risk Dermal tolerance Quote: “The rst panel started with Hi- biscrub, the second with Sterilium. Both products were used over seven weeks after one week of preconditioning. After an in- terval of four weeks the second run started with a single crossover of products.” Comment: although cross-over trial used, no indication that the participants or per- sonnel were blinded to the intervention Surgical hand disinfection Quote: “Organisms were recovered by the glove juice method. Plastic bags with the sampling uid were placed on the subjects hands. The bag on each hand was secured and massaged for 1 min in a uniform man- ner by a laboratory technician.” Comment: no indication whether partic- ipants were blinded to intervention and unclear whether technician was blinded to which intervention had been used Hygienic hand disinfection Quote: “The antimicrobial ef cacy of each product was compared with that of 60% (v/ v) 2-propanol on arti cially contaminated hands ( E. coliK 12, NCTC 10 538) us- ing a cross-over design with 15 volunteers.
The hands were rst washed for 1 min with soft soap, dried with paper towels immersed in the contamination uid up to the mid- metacarpals for 5 s with ngers spread and then allowed to dry for 3 min” 58 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pietsch 2001(Continued) Comment: unclear as to whether partici- pants or personnel were blinded to the in- terventions Blinding (performance bias and detection bias) All outcomes - Blinding care givers Unclear risk Dermal tolerance Quote: “The rst panel started with Hi- biscrub, the second with Sterilium. Both products were used over seven weeks after one week of preconditioning. After an in- terval of four weeks the second run started with a single crossover of products” Comment: although cross-over design used, no indication that the participants or personnel were blinded to the intervention Surgical hand disinfection Quote: “Organisms were recovered by the glove juice method. Plastic bags with the sampling uid were placed on the subjects hands. The bag on each hand was secured and massaged for 1 min in a uniform man- ner by a laboratory technician” Comment: no indication whether partic- ipants were blinded to intervention and unclear whether technician was blinded to which intervention had been used Hygienic hand disinfection Quote: “The antimicrobial ef cacy of each product was compared with that of 60% (v/ v) 2-propanol on arti cially contaminated hands ( E. coliK 12, NCTC 10 538) us- ing a cross-over design with 15 volunteers.
The hands were rst washed for 1 min with soft soap, dried with paper towels immersed in the contamination uid up to the mid- metacarpals for 5 s with ngers spread and then allowed to dry for 3 min.” Comment: unclear as to whether partici- pants or personnel were blinded to the in- terventions Blinding (performance bias and detection bias) All outcomes - Blinding outcome assessors Unclear risk Dermal tolerance Quote: “The following parameters were measured before and after application:
Clinical assessment by observation of the hands and the forearms of the volunteers by a dermatologist. The number of volunteers which dropped out of the study because of skin damage as decided by a dermatologist” Comment: no indication that the derma- 59 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pietsch 2001(Continued) tologist was independent to the study Surgical hand disinfection Quote: “The bag on each hand was secured and massaged for 1 min in a uniform man- ner by a laboratory technician” Comment: no indication that the labora- tory technician was blinded to the inter- vention Hygienic hand disinfection Quote: “Control microbial counts were obtained by rubbing the ngertips for 1 minute in a Petri dish containing a liquid broth using a separate dish for each hand.
Either 3 ml of the hand gel or two aliquots of 3 ml of the reference alcohol were ap- plied to the hands. The rub-in period was 30 s for the hand gels and 60 s for the ref- erence alcohol as prescribed by EN 1500.” Comment: no mention of whether those supervising the process or the overseeing the microbial assays were independent of the study Incomplete outcome data (attrition bias) All outcomes Unclear risk Dermal tolerance Quote: “A dramatic nding is the very high number of subjects dropping out of the Hi- biscrub group. Altogether 15 persons gave up using the Hibiscrub for reasons related to the use of the product, but there was only person who discontinued Sterillium.” Comment: This total represented a large proportion of the total participants used.
Despite attributing the high rates of dropout to reasons related to the product, the risk of attrition bias is fairly high in this case Surgical hand disinfection No direct quotes, but no indication given as to the total number of participants used or whether there was any observed loss to fol- low-up. Therefore the judgement remains unclear Hygienic hand disinfection Quote:“The antimicrobial ef cacy of each product was compared with that of 60% (v/ v) 2-propanol on arti cially contaminated hands ( E. coliK 12, NCTC 10538) using a cross-over design with 15 volunteers.” Comment: No losses to follow-up were dis- 60 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Pietsch 2001(Continued) cussed within the results; however, there is no evidence to suggest no losses to follow- up occurred. Overall judgement therefore remains unclear for outcome assessment Selective reporting (reporting bias) Low risk Dermal tolerance No direct quotes; however, the form used to tabulate the results gives no quanti- tative gures for variables that were pre- dominantly quantitative in nature. For ex- ample “D-squames”, “Electrical capacity”, “Transepidermal water loss” are expressed as either “ very poor”, “ poor”, “+ good” or “++ very good”. It is unclear why the outcomes have been reported in this way Surgical hand disinfection No direct quotes, although the results in- dicate the microbial concentration in the sampling uid before and after treatment, outlined in the methodology and expressed as logarithm Hygienic hand disinfection No direct quotes, although all the hand disinfectants that were discussed in the methodology as appropriate for testing are discussed and tabulated in an appropriate manner. Overall judgement of low risk Other bias Low risk No other sources of bias detected; cross- over design taken into account in analysis Tanner 2009 Methods Parallel group randomised controlled trial. Unit of randomi sation and analysis is indi- vidual staff member Generation of random number sequence: computerised generati on Allocation concealment: sealed opaque envelopes Blinding: blinded outcome assessment A priori sample calculations: yes Antisepsis protocol: yes Withdrawals: details given of small number not included in an alysis Intention-to-treat analysis: no Clear inclusion or exclusion criteria: yes Participants 164 nurses, operating department practitioners and healthca re assistants 61 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Tanner 2009(Continued) Interventions Group 1 - chlorhexidine (aqueous chlorhexidine gluconate 4% (Hib iscrub)) alone. Total application time of 2 min, n = 54 Group 2 - chlorhexidine as group 1 plus cleaning nails with disp osable nail pick (before scrub under running water), n = 54 Group 3 - chlorhexidine as above plus cleaning nails with dispo sable nail brush (before scrub under running water), n = 54 All groups were observed and timed when scrubbing. Total anti septic application time in each group was 2 min (measured dose of 2 x 2 ml for 1 min/dose) Outcomes Primary outcome: number of CFUs on dominant hand Method of testing: modi ed glove juice method (sterile Gammex Powder Free, Ansell glove) Notes No surgical procedures were performed; all staff performed cir culating duties within the operating theatre for 1 h Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk An appropriate method of generating the randomisation sequence was reported:
”Randomisation was in random size blocks in multiples of three and was generated by a statistician using a computer software pack- age.“ Allocation concealment (selection bias) Low risk A recognised method for ensuring alloca- tion concealment was reported: ”Group al- location details were placed inside sequen- tially numbered sealed opaque envelopes by an individual independent from the study.
The envelopes were opened by participants after baseline bacterial counts had been taken and immediately before the scrub in- tervention was performed. The researcher conducting the baseline sample was un- aware of each participant’s group alloca- tion.“ Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk Scrub protocols differed such that all par- ticipants were aware of their allocation Blinding (performance bias and detection bias)All outcomes - Blinding care givers High risk For personnel (not caregivers): ”The re- searcher conducting the baseline sample was unaware of each participant’s group allocation. As the researcher observed the 62 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Tanner 2009(Continued) participants’ scrubbing they were therefore aware of each participant’s group allocation when conducting the post-scrub sample.” Blinding (performance bias and detection bias) All outcomes - Blinding outcome assessors Low risk CFU assessment was performed in a blinded manner: “Laboratory staff estimat- ing the bacterial counts were unaware of group allocation status.” Incomplete outcome data (attrition bias)All outcomes Low risk Data missing for only 2 participants; rea- sons given: ”164 operating department staff took part in the study. No participants dropped out, but the laboratory results for two people were spoiled. The ndings on 162 participants are presented.” Selective reporting (reporting bias) Low risk All speci ed outcomes reported: “The pri- mary purpose of the trial was to compare any two of the trial groups by measuring the difference in post-intervention CFU per hand. A secondary purpose was to identify any relationships between participants and baseline CFU counts.” Other bias Low risk No evidence of other sources of bias Vergara-Fernandez 2010 Methods Parallel group randomised controlled trial. Unit of randomi sation and analysis is patient Generation of random number sequence: not reported Allocation concealment: sealed envelopes, no further informa tion Blinding: not reported A priori sample calculations: no Antisepsis protocol: no Withdrawals: no patient withdrawals for evaluation of SSI; CFUs only assessed for 20% of staff but all included in analysis. Intention-to-treat analysis: yes Clear inclusion or exclusion criteria: types of surgery only Participants 400 staff classi ed as surgeons, “instrumentalists” and hel pers 100 patients undergoing clean or clean-contaminated surgery Interventions Group 1 - aqueous scrub with 4% chlorhexidine gluconate with bru sh and sterile water.
Mean duration of scrub 3.9 (SD 1.07) min Group 2 - alcohol rub with 61% ethanol, 1% chlorhexidine glucona te. Mean duration 2.0 (SD 0.47) min 63 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Vergara-Fernandez 2010(Continued) Outcomes SSI after 1 month (CDC criteria; method of diagnosis not furthe r reported) CFUs on hands (20% of personnel only): reports number of person nel with positive cultures (no further detail) Notes Only 20% of the 400 enrolled staff were assessed for bacteria o n hands; these were classi ed as having or not having a positive culture. No data on number of CFUs on hands were reported Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Just says “used closed envelopes” Allocation concealment (selection bias) Unclear risk Just says “used closed envelopes” Blinding (performance bias and detection bias) All outcomes - Blinding participants Unclear risk No information given but interventions clearly differed Blinding (performance bias and detection bias)All outcomes - Blinding care givers Unclear risk No information given but interventions clearly differed Blinding (performance bias and detection bias)All outcomes - Blinding outcome assessors Unclear risk No information on blinding of outcome assessors Incomplete outcome data (attrition bias)All outcomes Low risk Data on all patients reported for SSI Data on 20% of personnel collected for CFUs; results reported for all those col- lected Selective reporting (reporting bias) Low risk All speci ed outcomes reported Other bias Low risk No other sources of bias detected 64 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Wheelock 1997 Methods Randomised cross-over trialGeneration of random number sequence: no details given Allocation concealment: no details given Blinding: no details given (dermal tolerance) A priori sample calculations: yes Antisepsis protocol: yes Withdrawals: no details given Intention-to-treat analysis: no Clear inclusion or exclusion criteria: no Participants 25 operating theatre nurses and surgical technologistsBaseline comparability: age, gender, hand size, role, lengt h of perioperative experience Interventions Group 1 - 3 min surgical scrub using either 4% chlorhexidine, 2% ch lorhexidine or parachlorometaxylenol Group 2 - 2 min surgical scrub using either 4% chlorhexidine, 2%ch lorhexidine or parachlorometaxylenol Outcomes Outcome measure: CFUs on participants’ hands Method of testing: glove juice method Timing of testing: 1 h after antisepsis Notes Participants did not take part in any surgical procedures. Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk Quote “We randomly assigned subjects to one of two study groups (i.e., two-minute, three-minute surgical hand scrub times).” Comment: no indication as whether a truly randomised sequence was generated Allocation concealment (selection bias) Unclear risk Quote “We randomly assigned subjects to one of two study groups (i.e., two-minute, three-minute surgical hand scrub times).” Comment: no indication as to whether al- location was concealed to the participants or personnel. The study was a cross-over trial, therefore all the participants were likely to have undertaken the same inter- ventions; however, the role of bias is un- clear in this case Blinding (performance bias and detection bias) All outcomes - Blinding participants High risk No direct quotes given, but no mention as to whether the subjects or the personnel were blinded to the intervention. It is very likely that the personnel were not blinded 65 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Wheelock 1997(Continued) as they would be able to calculate the time spent handwashing Blinding (performance bias and detection bias) All outcomes - Blinding care givers High risk No direct quotes given, but no mention as to whether the subjects or the personnel were blinded to the intervention. It is very likely that the personnel were not blinded as they would be able to calculate the time spent handwashing Blinding (performance bias and detection bias)All outcomes - Blinding outcome assessors High risk No direct quotes given, but investigators were responsible for measurement of time and for preparation of solution for bacterial culture, as well as the sampling and mea- surement of log CFU counts. Although this is an objective measure, it is reasonable to suggest that as the investigators were not blinded to the intervention then the risk of bias here could be considered as high Incomplete outcome data (attrition bias)All outcomes Low risk Quote: “Each subject was able to complete both surgical hand scrub trials, which re- sulted in 300 agar plates for incubation and enumeration.” Comment: adequate evidence of no loss to follow-up Selective reporting (reporting bias) Low risk The main outcome variable was the log counts of bacterial colonies found on par- ticipants’ hands after washing their hands for a speci ed time. This was fully repre- sented in table format in the results section Other bias Unclear risk Although the trial had a cross-over design.
it did not appear that this was re ected in the analysis AAS : aqueous alcohol solution; ABWA: alcohol-based water-aided; ASA: American Society of Anesthesiologists; CDC: Centers for Disease Control; CFU: colony forming units; CHG: chlorhexidine gluconate; C/S: culture and sensitivity PVI: povidone iodine; SSI : surgical site infection; v/v: volume/volume per cent. 66 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Characteristics of excluded studies[ordered by study ID] Study Reason for exclusion Adjoussou 2009 Not a randomised controlled trial Aly 1983 A laboratory-based study Aly 1988 A laboratory-based study Aly 1998 Evaluated patient skin preparations Arata 1993 Evaluated patient skin preparations Ayliffe 1984 A discussion paper Ayliffe 1988 A laboratory and ward study - not hand antisepsis Ayliffe 1990 Hand hygiene study Babb 1991 Study carried out on volunteers, not scrub staff in an operatin g theatre Bansal 2002 Wound irrigation study Barsanti 2009 Infection in ITU Bartzokas 1983 A laboratory-based study Bearman 2010 Gloving study Beeuwkes 1986 Participants were not randomised Bendig 1990 A laboratory-based study Bernam 2004 Not a randomised controlled trial Bibbo 2005 Evaluated patient skin preparations Blomgren 1983 Body exhaust suit study Borer 2001 Infection surveillance study Boyce 2000a An editorial Boyce 2000b Evaluated skin condition rather than SSIs or CFUs Braumann 2008 Study of dressings 67 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Breeze 1994 Discussion paper Brooks 2001 Evaluated patient skin preparations Bruckner 2009 Study of dressings Bryce 2001 Not a randomised controlled trial. Participants used product A for 2 weeks then swapped to product B for the following 2 weeks Caelli 2000 Study of MRSA decolonisation Carro 2007 Not a randomised controlled trial Cheng 2001 Literature review Coelho 1984 Not relevant to this review Cremieux 1989 A laboratory-based study Crowder 1967 Study was not randomised. Participants performed antisepsi s using their usual solution. There were no comparison groups Culligan 2005 Randomised controlled trial comparing antiseptic solutions on patients’ skin Curti 1974 Chemical agents Da Cunha 2011 Not a randomised controlled trial Dahl 1990 Chlorhexidine scrub which was left on the surgeons arm was compa red with a surgeons arm where the chlorhexidine scrub was rinsed off. Did not meet the objectives of this review Das 2005 Study on hygienic hand washing De Castro Peraza 2010 Study of gloves in surgery Demir 2009 Staff survey Deshmukh 1998 Participants were randomised to 2 groups. Group 1 participant s were tested after 1 hour and group 2 participants were tested after 2 hours. Participants in both g roups used product A 1 day and product B the next day Dineen 1969 Participants’ hands were covered with bacterial inoculum. A lab oratory-based study Dineen 1978 A laboratory-based study Dohmen 2006 Antibiotic prophylaxic study 68 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Durani 2008 Non-systematic literature review Elenbaas 1982 Dog bite study Ellenhorn 2005 Evaluated patient skin preparations Faoagali 1995 A laboratory style study using non clinical hospital staff Ford 2005 Antimicrobial suture study Grabsch 2004 Not randomised Grinbaum 1995 A retrospective study Gruendemann 2001 Discussion paper Guilhermetti 2001 MRSA decontamination study Hagen 1995 Evaluated patient skin preparations Harnoss Study carried out on volunteers, not scrub staff in an operatin g theatre Heeg 1986 Experimental and clinical conditions Heeg 2001 Measured the impact of hand care products on alcohol rubs Heeg 2008 Testing methods not suitable; not randomised Hibbard 2002a A laboratory-based study Hibbard 2002b A laboratory-based study Hingst 1992 A laboratory-based study Hobson 1998 A laboratory-based study Hubner 2006 A laboratory-based study Incoll 2009 Skin preparation of patient Jeng 1998 A laboratory-based study Jeng 2001 A study of skin antiseptics used on patients skin Jones 2000 A laboratory-based study and participants were not randomise d 69 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Joress 1962 No comparison group was used in the rst part of the trial. Comp arison groups were used in the second part of the trial, but solutions were applied to the forearm r ather than as surgical scrubs Kampf 2005 A laboratory-based study Kargi 2008 Anaesthetic agents study Keser 2005 Not a randomised controlled trial Kikuchi 1999 Measured condition of skin on hands of participants; did not com pare CFUs or SSIs Kjellander 1960 Not randomised Kong 1994 Not relevant topic. Kramer 2007 Not randomised Kramer 2008 Descriptive paper of scrubbing methods Larson 1984 Study focused on handwashing rather than hand antisepsis Larson 1986a A laboratory-based study Larson 1986b A laboratory-based study Larson 1990 A laboratory-based study Larson 1993 A laboratory-based study Larson 2001a Study of handwashing in intensive care Larson 2001b Not randomised to appropriate groups. 5 participants were randomised to a reference group at the beginning of the study. The participants randomised to the interventio n group used an alcohol rub for 3 weeks and then a surgical scrub for 3 weeks Lehmann 1985 Analgesics study Lepor 2009 Patient skin prep study Lilly 1978 A laboratory-based study Lio 2009 Study on topical agents Llanos 2006 Wound management Loeb 1997 Study carried out on volunteers, not scrub staff in an operatin g theatre 70 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Lowbury 1974a Not relevant to this review Lowbury 1974b A laboratory-based study Lung 2004 A literature review Magann 1993 Evaluated patient skin preparations Magera 2007 Patient skin preparation study Marchetti 2003 Laboratory-based study Marra 2008 Hand hygiene study Mathias 2000 A discussion paper Mathias 2002 A discussion paper McBride 1973 A laboratory-based study Meers 1978 Not relevant topic Minakuchi 1993 A study of handwashing rather than hand antisepsis. Misterka 1991 Study of dressings Moralejo 2003 Not a randomised controlled trial; summary of previously pub lished studies Mulberry 2001 A laboratory-based study Murie 1980 Cross-over trial but without any randomisation Nakano 2008 Wound irrigation study Nowak 1982 Bowel prep study O’Shaughnessy 1991 All participants carried out intervention 1 on day 1, intervention 2 on day 2 and intervention 3 on day 3 No randomisation Olson 2012 Study carried out on volunteers, not scrub staff in an operatin g theatre Ortiz 2012 Assessed intra-operative rescrubbing Parienti 2004 Central venous catheter study Paulson 1994 A laboratory-based study 71 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Paulson 1999 A laboratory-based study Peterson 1978 A laboratory-based study Phimolsarnti 1986 Not randomised Poon 1998 Not randomised Rehork 1991 Study carried out on volunteers, not scrub staff in an operatin g theatre Reid 1991 Study of wound management Reverdy 1984 A laboratory-based study Rotter 1980 A laboratory-based study Rotter 1984 Study of handwashing rather than hand antisepsis Rotter 1986 A laboratory-based study Rotter 1998 A laboratory-based study Rotter 2005 Explores hand hygiene rather than hand antisepsis Rotter 2006 Laboratory-based study Sattar 2000 A laboratory-based study Scheibel 1991 Study of clean air systems Scott 1991 Evaluated user satisfaction Sensoz 2003 No evidence that the study was randomised Serra 2005 Study of dressings Shirahatti 1993 Evaluated patient skin preparations Simor 2007 MRSA decolonisation Springer 2002 Discussion paper Stahl 2007 Lab based study of effect of saline in antimicrobial skin preparations Starr 2005 Evaluated patient skin preparations Stevenson 2003 Study of antibiotics 72 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. (Continued) Sullivan 2008 Patient skin preparation study Tanner 2008 Earlier systematic review Thiele 2008 Literature review Tucci 1977 Not a randomised controlled trial; no control group Valente 2003 Wound irrigation study Vogt 2006 Evaluated iodine based wound dressings Voss 1997 Looked at compliance with various handwashing methods Vossinakis 2004 Study of local anaesthetic Walwaikar 2002 Each intervention group contained a scrub solution, a patient p rep solution and a follow-up wound cleansing product. It was not possible to look at the effect of the scrub sol ution on its own Waterman 2006 Study of glove juice and rings Webster 1989 Study of handwashing in a neo-natal unit Wernze 1975 Anaesthetics study Whittaker 2005 Study of antibiotics in hand injuries Yeung 2007 Hand hygiene literature review Yuldashkhan 2008 Not a randomised controlled trial Zaragoza 1999 A study of handwashing, not hand antisepsis. MRSA: methicillin-resistant Staphylococcus aureus Characteristics of studies awaiting assessment [ordered by study ID] Chen 2012 Methods Participants Interventions 73 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Chen 2012(Continued) Outcomes Notes Awaiting information from author 74 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. D A T A A N D A N A L Y S E S Comparison 1. basic hand hygiene versus alcohol rub Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 SSI 1 3133 Risk Ratio (M-H, Fixed, 95% CI) 0.97 [0.77, 1.23] Comparison 2. chlorhexidine versus iodine Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 CFUs 3 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 CFUs immediately after antisepsis 3 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 CFUs 2 h after initial antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.3 CFUs 2 h after subsequent antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.4 CFUs after surgical procedure 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Comparison 3. chlorhexidine versus iodine plus triclosan Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 CFUs immediately after antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 CFUs 2 h after initial antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.3 CFUs 2 h after subsequent antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 75 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Comparison 4. alcohol rub versus other alcohol rub Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 Immediately after antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 2 h after initial antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.3 2 h after subsequent antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Comparison 5. scrub versus alcohol-only rub Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 SSI 1 500 Risk Ratio (M-H, Fixed, 95% CI) 0.56 [0.23, 1.34] Comparison 6. scrub versus alcohol rub Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 SSI 2 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only Comparison 7. scrub (chlorhexidine) versus alcohol rub + additional i ngredient Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 Immediately after antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 After surgical procedure 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 76 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Comparison 8. scrub (povidone iodine) versus alcohol rub + additionalingredient Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 Immediately after antisepsis 0 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 After surgical procedure 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Comparison 9. scrub (chlorhexidine) versus rub + additional ingredi ent Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 Immediately after antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 After surgical procedure 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Comparison 10. scrub (chlorhexidine) versus alcohol rub + additional ingredient Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUs 1 53 Mean Difference (IV, Fixed, 95% CI) -135.6 [-153.39, - 117.81] Comparison 11. duration - Kappstein (5 minutes versus 3 minutes) Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUs immediately after antisepsis 1 48 Mean Difference (IV, Fixed, 95% CI) 0.26 [0.14, 0.38] 77 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Comparison 12. duration - 5 + 3 min versus 3 + 0.5 min with chlorhexidine) Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 Immediately after antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 2 h after initial antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.3 2 h after subsequent antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Comparison 13. duration - 5 + 3 min versus 3 + 0.5 minutes with iodine) Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 Immediately after antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 After initial antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.3 2 h after subsequent antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] Comparison 14. duration - 5 + 3.5 min versus 3 + 2.5 min chlorhexidine) Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 CFUs 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected 1.1 Immediately after antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.2 2 h after initial antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 1.3 2 h after subsequent antisepsis 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0] 78 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Comparison 15. scrub versus scrub plus brush Outcome or subgroup titleNo. of studies No. of participants Statistical method Effect size 1 CFUS 1 108 Mean Difference (IV, Fixed, 95% CI) 0.24 [-0.03, 0.51] Comparison 16. scrub versus scrub plus nail pick Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 CFUs 1 108 Mean Difference (IV, Fixed, 95% CI) 0.13 [-0.14, 0.40] Comparison 17. scrub plus brush versus scrub plus nail pick Outcome or subgroup title No. of studies No. of participants Statistical method Effect size 1 CFUs 1 108 Mean Difference (IV, Fixed, 95% CI) 0.11 [-0.16, 0.38] Analysis 1.1. Comparison 1 basic hand hygiene versus alcoho l rub, Outcome 1 SSI.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 1 basic hand hygiene versus alcohol rub Outcome: 1 SSI Study or subgroup Scrub (soap and water) Alcohol rub Risk Ratio Weight Risk Ratio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Nthumba 2010 128/1596 127/1537 100.0 % 0.97 [ 0.77, 1.23 ] Total (95% CI) 1596 1537 100.0 % 0.97 [ 0.77, 1.23 ] Total events: 128 (Scrub (soap and water)), 127 (Alcohol rub ) Heterogeneity: not applicable Test for overall effect: Z = 0.25 (P = 0.80) Test for subgroup differences: Not applicable 0.01 0.1 1 10 100 Favours soap and water Favours rub 79 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 2.1. Comparison 2 chlorhexidine versus iodine, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 2 chlorhexidine versus iodine Outcome: 1 CFUs Study or subgroup Chlorhexidine Iodine Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 CFUs immediately after antisepsis Furukawa 2005 11 0.1 (0.4) 11 2.5 (1.4) -2.40 [ -3.26, -1.54 ] Herruzo 2000 50 18 (6) 49 66 (7) -48.00 [ -50.57, -45.43 ] Pereira 1990 34 3.99 (0.7) 34 4.33 (0.56) -0.34 [ -0.64, -0.04 ] Pereira 1990 34 4.11 (0.23) 34 4.28 (0.23) -0.17 [ -0.28, -0.06 ] 2 CFUs 2 h after initial antisepsis Pereira 1990 34 3.6 (0.64) 34 4.35 (0.65) -0.75 [ -1.06, -0.44 ] Pereira 1990 34 3.83 (0.56) 34 4.24 (0.74) -0.41 [ -0.72, -0.10 ] 3 CFUs 2 h after subsequent antisepsis Pereira 1990 34 3.44 (0.81) 34 4.54 (0.48) -1.10 [ -1.42, -0.78 ] Pereira 1990 34 4.02 (0.63) 34 4.67 (0.54) -0.65 [ -0.93, -0.37 ] 4 CFUs after surgical procedure Herruzo 2000 50 37 (11) 49 169 (31) -132.00 [ -141.20, -122.80 ] -1 -0.5 0 0.5 1 Favours Chlorhex. Favours Iodine 80 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 3.1. Comparison 3 chlorhexidine versus iodine plus triclosan, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 3 chlorhexidine versus iodine plus triclosan Outcome: 1 CFUs Study or subgroup Chlorhexidine Iodine triclosan Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 CFUs immediately after antisepsis Pereira 1997 23 4.41 (0.73) 23 4.79 (0.86) -0.38 [ -0.84, 0.08 ] 2 CFUs 2 h after initial antisepsis Pereira 1997 23 4.05 (0.98) 23 4.43 (0.8) -0.38 [ -0.90, 0.14 ] 3 CFUs 2 h after subsequent antisepsis Pereira 1997 23 4.13 (0.88) 23 4.82 (0.64) -0.69 [ -1.13, -0.25 ] -2 -1 0 1 2 Favours Chlorhex Favours Iodine tri Analysis 4.1. Comparison 4 alcohol rub versus other alcohol rub, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 4 alcohol rub versus other alcohol rub Outcome: 1 CFUs Study or subgroup Isopropanol Ethanol Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 Immediately after antisepsis Pereira 1997 23 3.96 (0.96) 23 3.96 (1.01) 0.0 [ -0.57, 0.57 ] 2 2 h after initial antisepsis Pereira 1997 23 3.52 (0.82) 23 3.45 (0.97) 0.07 [ -0.45, 0.59 ] 3 2 h after subsequent antisepsis Pereira 1997 23 3.87 (0.96) 23 3.76 (1.11) 0.11 [ -0.49, 0.71 ] -2 -1 0 1 2 Favours Isopropanol Favours Ethanol 81 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 5.1. Comparison 5 scrub versus alcohol-only rub, Outcome 1 SSI.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 5 scrub versus alcohol-only rub Outcome: 1 SSI Study or subgroup Alcohol rub Aqueous scrub Risk Ratio Weigh t Risk Ratio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Al-Naami 2009 8/272 12/228 100.0 % 0.56 [ 0.23, 1.34 ] Total (95% CI) 272 228 100.0 % 0.56 [ 0.23, 1.34 ] Total events: 8 (Alcohol rub), 12 (Aqueous scrub) Heterogeneity: not applicable Test for overall effect: Z = 1.30 (P = 0.19) Test for subgroup differences: Not applicable 0.01 0.1 1 10 100 Favours alcohol Favours scrub Analysis 6.1. Comparison 6 scrub versus alcohol rub, Outcom e 1 SSI.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 6 scrub versus alcohol rub Outcome: 1 SSI Study or subgroup 4% chlorhexidine alcohol rub Risk Ratio We ight Risk Ratio n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI Parienti 2002 53/2135 55/2252 1.02 [ 0.70, 1.48 ] Vergara-Fernandez 2010 1/50 2/50 0.50 [ 0.05, 5.34 ] 0.01 0.1 1 10 100 Favours chlorhexidine Favours alcohol rub 82 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 7.1. Comparison 7 scrub (chlorhexidine) versus alcohol rub + additional ingredient, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 7 scrub (chlorhexidine) versus alcohol rub + ad ditional ingredient Outcome: 1 CFUs Study or subgroup Chlorhexidine Scrub N duo- propenide Rub Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 Immediately after antisepsis Herruzo 2000 50 18 (6) 55 1 (0) Not estimable 2 After surgical procedure Herruzo 2000 50 37 (11) 55 1 (0) Not estimable -10 -5 0 5 10 Favours Scrub Favours Rub 83 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 8.1. Comparison 8 scrub (povidone iodine) versus alcohol rub + additional ingredient, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 8 scrub (povidone iodine) versus alcohol rub + a dditional ingredient Outcome: 1 CFUs Study or subgroup Iodine Scrub N duo- propenide Rub Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 Immediately after antisepsis 2 After surgical procedure Herruzo 2000 49 169 (31) 55 1 (0) Not estimable Herruzo 2000 49 66 (7) 55 1 (0) Not estimable -2 -1 0 1 2 Favours Scrub Favours Rub Analysis 9.1. Comparison 9 scrub (chlorhexidine) versus ru b + additional ingredient, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 9 scrub (chlorhexidine) versus rub + additiona l ingredient Outcome: 1 CFUs Study or subgroup Rub Scrub Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 Immediately after antisepsis Pietsch 2001 75 2.94 (0.13) 75 4.21 (0.12) -1.27 [ -1.31, -1.23 ] 2 After surgical procedure Pietsch 2001 75 3.54 (0.13) 75 4.61 (0.09) -1.07 [ -1.11, -1.03 ] -1 -0.5 0 0.5 1 Favours Rub Favours Scrub 84 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 10.1. Comparison 10 scrub (chlorhexidine) versusalcohol rub + additional ingredient, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 10 scrub (chlorhexidine) versus alcohol rub + a dditional ingredient Outcome: 1 CFUs Study or subgroup Chlorhexine Scrub Alcohol Rub Mean Difference Weight Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI Hajipour 2006 25 3.1 (6.1) 28 138.7 (47.6) 100.0 % -135.60 [ -153.39, -117.81 ] Total (95% CI) 25 28 100.0 % -135.60 [ -153.39, -117.81 ] Heterogeneity: not applicable Test for overall effect: Z = 14.94 (P < 0.00001) Test for subgroup differences: Not applicable -100 -50 0 50 100 Favours scrub Favours rub Analysis 11.1. Comparison 11 duration - Kappstein (5 minute s versus 3 minutes), Outcome 1 CFUs immediately after antisepsis.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 11 duration - Kappstein (5 minutes versus 3 minu tes) Outcome: 1 CFUs immediately after antisepsis Study or subgroup 5 minutes 3 minutes Mean Difference Weight Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI Kappstein 1993 24 4.84 (0.21) 24 4.58 (0.22) 100.0 % 0.26 [ 0.14, 0.38 ] Total (95% CI) 24 24 100.0 % 0.26 [ 0.14, 0.38 ] Heterogeneity: not applicable Test for overall effect: Z = 4.19 (P = 0.000028) Test for subgroup differences: Not applicable -0.2 -0.1 0 0.1 0.2 Favours 5 minutes Favours 3 minutes 85 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 12.1. Comparison 12 duration - 5 + 3 min versus 3 + 0.5min with chlorhexidine), Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 12 duration - 5 + 3 min versus 3 + 0.5 min with chlor hexidine) Outcome: 1 CFUs Study or subgroup 5 minutes 3 minutes Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 Immediately after antisepsis Pereira 1990 34 3.99 (0.7) 34 4.18 (0.64) -0.19 [ -0.51, 0.13 ] 2 2 h after initial antisepsis Pereira 1990 34 3.6 (0.64) 34 3.83 (0.59) -0.23 [ -0.52, 0.06 ] 3 2 h after subsequent antisepsis Pereira 1990 34 3.44 (0.81) 34 4.02 (0.62) -0.58 [ -0.92, -0.24 ] -1 -0.5 0 0.5 1 Favours 5 minutes Favours 3 minutes Analysis 13.1. Comparison 13 duration - 5 + 3 min versus 3 + 0.5 minutes with iodine), Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 13 duration - 5 + 3 min versus 3 + 0.5 minutes with i odine) Outcome: 1 CFUs Study or subgroup 5 minutes 3 minutes Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 Immediately after antisepsis Pereira 1990 34 4.33 (0.56) 34 4.31 (0.7) 0.02 [ -0.28, 0.32 ] 2 After initial antisepsis Pereira 1990 34 4.35 (0.65) 34 4.23 (0.74) 0.12 [ -0.21, 0.45 ] 3 2 h after subsequent antisepsis Pereira 1990 34 4.54 (0.48) 34 4.67 (0.53) -0.13 [ -0.37, 0.11 ] -0.5 -0.25 0 0.25 0.5 Favours 5 minutes Favours 3 minutes 86 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 14.1. Comparison 14 duration - 5 + 3.5 min versus 3 + 2.5 min chlorhexidine), Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 14 duration - 5 + 3.5 min versus 3 + 2.5 min chlorhe xidine) Outcome: 1 CFUs Study or subgroup 5 minutes 3 minutes Mean Difference Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI 1 Immediately after antisepsis Pereira 1997 23 4.49 (1.03) 23 4.41 (0.73) 0.08 [ -0.44, 0.60 ] 2 2 h after initial antisepsis Pereira 1997 23 3.86 (1.13) 23 4.05 (0.89) -0.19 [ -0.78, 0.40 ] 3 2 h after subsequent antisepsis Pereira 1997 23 3.96 (1) 23 4.13 (0.88) -0.17 [ -0.71, 0.37 ] -1 -0.5 0 0.5 1 Favours 5 minutes Favours 3 minutes 87 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 15.1. Comparison 15 scrub versus scrub plus brush,Outcome 1 CFUS.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 15 scrub versus scrub plus brush Outcome: 1 CFUS Study or subgroup Experimental Control Mean Difference Weight Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI Tanner 2009 54 3.12 (0.696) 54 2.88 (0.714) 100.0 % 0.24 [ -0.03, 0.51 ] Total (95% CI) 54 54 100.0 % 0.24 [ -0.03, 0.51 ] Heterogeneity: not applicable Test for overall effect: Z = 1.77 (P = 0.077) Test for subgroup differences: Not applicable -100 -50 0 50 100 Favours scrub plus brush Favours scrub only Analysis 16.1. Comparison 16 scrub versus scrub plus nail pi ck, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 16 scrub versus scrub plus nail pick Outcome: 1 CFUs Study or subgroup Experimental Control Mean Difference Weight Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI Tanner 2009 54 3.01 (0.714) 54 2.88 (0.714) 100.0 % 0.13 [ -0.14, 0.40 ] Total (95% CI) 54 54 100.0 % 0.13 [ -0.14, 0.40 ] Heterogeneity: not applicable Test for overall effect: Z = 0.95 (P = 0.34) Test for subgroup differences: Not applicable -100 -50 0 50 100 Favours scrub plus nail p Favours scrub alone 88 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Analysis 17.1. Comparison 17 scrub plus brush versus scrub plus nail pick, Outcome 1 CFUs.
Review: Surgical hand antisepsis to reduce surgical site in fection Comparison: 17 scrub plus brush versus scrub plus nail pick Outcome: 1 CFUs Study or subgroup Scrub plus brush Scrub plus nail pick Mean Difference Weight Mean Difference N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI Tanner 2009 54 3.12 (0.696) 54 3.01 (0.714) 100.0 % 0.11 [ -0.16, 0.38 ] Total (95% CI) 54 54 100.0 % 0.11 [ -0.16, 0.38 ] Heterogeneity: not applicable Test for overall effect: Z = 0.81 (P = 0.42) Test for subgroup differences: Not applicable -100 -50 0 50 100 Favours scrub plus brush Favours scrub plus pick A D D I T I O N A L T A B L E S Table 1. Overview of included studies Trial arms Study 1 2 3 4 5 Country Trial involved Surgery SSI CFU Al-Naami 2009 n = 600 pa- tients (data on 500) Aqueous scrub Alcohol rub NA NA NA Saudi Ara- bia Clean and clean- contam- inated op- erations.
Mainly ab- dominal. CDC guidelines Furukawa 2005 n = 22 op- erating nurses Aqueous scrub Aqueous scrub NA NA NA Japan Iimme- diately af- ter antisep- sis; glove juice method 89 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Table 1. Overview of included studies(Continued) Gupta 2007 n = 22 op- erating staff Aqueous scrub Alcohol rub + ac- tive ingre- dient NA NA NA USA Oph- thalmic, po- diatric and general surgery Before an- tisepsis and imme- diately af- ter antisep- sis on day 1, after 6 hours on days 2 and 5; glove juice method Hajipour 2006 n = 4 sur- geons (ran- domised and tested 53 times) Aqueous scrub Alcohol rub + ac- tive ingre- dient alcohol rub + ac- tive ingre- dient NA NA UK Trauma At the end of the sur- gical pro- cedure; glove juice method Herruzo 2000 n = 154 sur- gical staff Aqueous scrub Aqueous scrub NA NA NA Spain Plas- tic surgery and trau- matology Before an- tisep- sis, imme- diately af- ter antisep- sis and at the end of the surgi- cal proce- dure; nger press testing with agar plates Kappstein 1993 * n = 24 sur- geons Aque- ous scrub 1 (dura- tion1) Aque- ous scrub 2 (duration 2) NA NA NA Germany Before an- tisepsis and imme- diately af- ter antisep- sis; glove juice method 90 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Table 1. Overview of included studies(Continued) Nthumba 2010 n = 66 sur- gical staff and 3317 patients Alcohol rub + ac- tive ingre- dient Stan- dard hand hygiene NA NA NA Kenya Clean and clean- contam- inated op- erations.
Mixed surgery types Mod- i ed CDC guidelines Parienti 2002 n = 4387 patients Aqueous scrub Alcohol rub + ac- tive ingre- dient NA NA NA France Mix of procedures CDC guidelines Pereira 1990 a n = 34 nurses Aqueous scrub 1 Duration 1 Aqueous scrub 2 Duration 1 Aqueous scrub 1 Duration 2 Aqueous scrub 2 Duration 2 NA Australia Imme- diately af- ter antisep- sis, 2 hours after initial antisep- sis, 2 hours after subse- quent anti- sepsis; glove juice method Pereira 1997 n = 34 oper- ating room nurses Aque- ous scrub 1 (dura- tion1) Aque- ous scrub 2 (duration 2) Aque- ous scrub 3 (duration 2) Alcohol rub + ac- tive ingre- dient 1 Alcohol rub + ac- tive ingre- dient 2 Australia Imme- diately af- ter antisep- sis, 2 hours after initial antisep- sis, 2 hours after subse- quent anti- sepsis; glove juice method Pietsch 2001 n= 75 sur- geons Aqueous scrub Alcohol rub + ac- tive ingre- dient NA NA NA Germany No detail Imme- diately af- ter antisep- sis and af- 91 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Table 1. Overview of included studies(Continued) ter surgical proce- dure com- pleted; glove juice method Tanner 2009 n= 164 staff Aqueous scrub Aqueous scrub +nail pick Aqueous scrub +nail brush NA NA UK 1 hour af- ter antisep- sis; modi ed glove juice method Vergara- Fernandez 2010 n = 100 pa- tients Aqueous scrub Alcohol rub + ac- tive ingre- dient NA NA NA Mexico Clean and clean- contam- inated op- erations.
Mixed surgery types CDC guidelines Only 20% of the 400 enrolled staff were assessed for bacteria on hands; data not included Wheelock 1997 n = 25 op- erat- ing theatre nurses and sur- gical tech- nologists Aque- ous scrub 1 (duration 1) Aque- ous scrub 2 (duration 2) NA NA NA USA 1 hour af- ter antisep- sis; glove juice method NA : not applicable 92 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. A P P E N D I C E S Appendix 1. Search methods used in previous versions Original review (2007) Cochrane Wounds Group Specialised Register (Searched 12 June 20 07); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2); Ovid MEDLINE (2005 to May Week 5 2007); Ovid EMBASE (2005 to 2007 Week 23); Ovid CINAHL (2005 to June Week 2 2007); ZETOC database of conference proceedings was searched from 1993 to 2005.
The following search strategy was used for searching CENTRAL:
1 MeSH descriptor Surgical Wound Infection explode all trees 2 surgical NEAR infection* 3 surgical NEAR wound* 4 (post-operative or postoperative) NEAR (wound NEXT infection *) 5 MeSH descriptor Preoperative Care explode all trees 6 MeSH descriptor Perioperative Care explode all trees 7 preoperative or pre-operative 8 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7) 9 MeSH descriptor Skin explode all trees 10 MeSH descriptor Antisepsis explode all trees 11 (#9 AND #10) 12 antisepsis 13 MeSH descriptor Iodine explode all trees 14 MeSH descriptor Iodophors explode all trees 15 MeSH descriptor Povidone-Iodine explode all trees 16 MeSH descriptor Chlorhexidine explode all trees 17 MeSH descriptor Alcohols explode all trees 18 MeSH descriptor Soaps explode all trees 19 MeSH descriptor Detergents explode all trees 20 MeSH descriptor Disinfection explode all trees 21 iodophor* or povidone-iodine or betadine or chlorhexidine or alcohol or alcohols or antiseptic* or soap* or detergent* or dis infect* 22 (#11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21) 23 MeSH descriptor Handwashing explode all trees 24 hand or hands or handwash* or surgical scrub*) 25 (#23 OR #24) 26 (#8 AND #22 AND #25) Appendix 2. Ovid MEDLINE search strategy 1 exp Surgical Wound Infection/ 2 exp Surgical Wound Dehiscence/ 3 (surg* adj5 infect*).tw.
4 (surg* adj5 wound*).tw.
5 (surg* adj5 site*).tw.
6 (surg* adj5 incision*).tw.
7 (surg* adj5 dehiscen*).tw.
8 ((post-operative or postoperative) adj5 wound infection*).tw .
9 exp Preoperative Care/ 93 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. 10 exp Perioperative Care/ 11 ((preoperative or pre-operative) adj care).tw.
12 or/1-11 13 exp Skin/ 14 exp Antisepsis/ 15 and/13-14 16 skin antisep*.tw.
17 exp Anti-Infective Agents, Local/ 18 exp Iodophors/ 19 exp Povidone-Iodine/ 20 exp Chlorhexidine/ 21 exp Alcohols/ 22 exp Soaps/ 23 (iodophor* or povidone-iodine or betadine or chlorhexidineor triclosan or hexachlorophene or benzalkonium or alcohol or a lcohols or antiseptic* or soap*).tw.
24 exp Disinfectants/ 25 13 and 24 26 (skin adj5 disinfect*).tw.
27 exp Detergents/ 28 13 and 27 29 (skin adj5 detergent*).tw.
30 or/15-23,25-26,28-29 31 exp Handwashing/ 32 exp Hand/ 33 (hand or hands or handwash* or surgical scrub*).tw.
34 or/31-33 35 12 and 30 and 34 Appendix 3. Ovid EMBASE search strategy 1 exp Surgical Wound Infection/ 2 exp Surgical Wound Dehiscence/ 3 (surg* adj5 infect*).tw.
4 (surg* adj5 wound*).tw.
5 (surg* adj5 site*).tw.
6 (surg* adj5 incision*).tw.
7 (surg* adj5 dehiscen*).tw.
8 ((post-operative or postoperative) adj5 wound infection*).tw .
9 exp Preoperative Care/ 10 exp Perioperative Care/ 11 ((preoperative or pre-operative) adj care).tw.
12 or/1-11 13 exp Skin/ 14 exp Antisepsis/ 15 and/13-14 16 skin antisep*.tw.
17 exp Anti-Infective Agents, Local/ 18 exp Iodophors/ 19 exp Povidone-Iodine/ 20 exp Chlorhexidine/ 21 exp Alcohols/ 22 exp Soaps/ 94 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. 23 (iodophor* or povidone-iodine or betadine or chlorhexidineor triclosan or hexachlorophene or benzalkonium or alcohol or a lcohols or antiseptic* or soap*).tw.
24 exp Disinfectants/ 25 13 and 24 26 (skin adj5 disinfect*).tw.
27 exp Detergents/ 28 13 and 27 29 (skin adj5 detergent*).tw.
30 or/15-23,25-26,28-29 31 exp Handwashing/ 32 exp Hand/ 33 (hand or hands or handwash* or surgical scrub*).tw.
34 or/31-33 35 12 and 30 and 34 Appendix 4. EBSCO CINAHL search strategy S32 S12 and S25 and S31 S31 S26 or S27 or S28 or S29 or S30 S30 TI ( surgical scrub*) or AB ( surgical scrub*) S29 TI ( hand or hands or handwash*) or AB ( hand or hands or hand wash*) S28 (MH “Surgical Scrubbing”) S27 (MH “Hand+”) S26 (MH “Handwashing+”) S25 S13 or S14 or S15 or S16 or S17 or S18 or S19 or S20 or S23 or S24 S24 TI skin N5 disinfect* or AB skin N5 disinfect* S23 S21 and S22 S22 (MH “Skin+”) S21 (MH “Disinfectants”) S20 TI ( iodophor* or povidone-iodine or betadine or chlorhexi dine or triclosan or hexachlorophene or benzalkonium or alcoho l or alcohols or antiseptic* or soap* or detergent* ) or AB ( iodopho r* or povidone-iodine or betadine or chlorhexidine or triclosan or hexachlorophene or benzalkonium or alcohol or alcohols or anti septic* or soap* or detergent* ) S19 (MH “Detergents+”) S18 (MH “Soaps”) S17 (MH “Alcohols+”) S16 (MH “Chlorhexidine”) S15 (MH “Povidone-Iodine”) S14 (MH “Iodine”) S13 TI antisepsis or AB antisepsis S12 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11 S11 TI ( preoperative care or pre-operative care) or AB ( preoper ative care or pre-operative care) S10 (MH “Perioperative Care+”) S9 (MH “Preoperative Care+”) S8 TI ( postoperative* N5 wound infection* OR post-operative* N5 wound infection* ) or AB ( postoperative* N5 wound infection * OR post-operative* N5 wound infection* ) S7 TI surg* N5 dehiscen* or AB surg* N5 dehiscen* S6 TI surg* N5 incision* or AB surg* N5 incision* S5 TI surg* N5 site* or AB surg* N5 site* S4 TI surg* N5 wound* or AB surg* N5 wound* S3 TI surg* N5 infection* or AB surg* N5 infection* S2 (MH “Surgical Wound Dehiscence”) S1 (MH “Surgical Wound Infection”) 95 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Appendix 5. Risk of Bias assessment 1. Was the allocation sequence randomly generated?
Low risk of bias The investigators describe a random component in the sequence generation process, such as referring to a random number table;using a computer random number generator; tossing a coin; shuf ing ca rds or envelopes; throwing dice; drawing of lots.
High risk of bias The investigators describe a non-random component in the seque nce generation process. Usually, the description would involve some systematic, non-random approach, for example, sequence genera ted by odd or even date of birth; sequence generated by some rul e based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.
Unclear Insuf cient information about the sequence generation proces s available to permit a judgement of low or high risk of bias.
2. Was the treatment allocation adequately concealed?
Low risk of bias Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equ ivalent method, was used to conceal allocation: central allocation (includ ing telephone, web-based and pharmacy-controlled randomisation); sequentially numbered drug containers of identical appearan ce; sequentially numbered, opaque, sealed envelopes.
High risk of bias Participants or investigators enrolling participants could p ossibly foresee assignments and thus introduce selection bia s, such as allocation based on using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or w ere not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.
Unclear Insuf cient information to permit judgement of low or high ri sk of bias. This is usually the case if the method of concealment i s not described or is not described in suf cient detail to allow a de n itive judgement, for example, if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequ entially numbered, opaque and sealed.
3. Blinding (participants, personnel and outcome assessor s) - was knowledge of the allocated interventions adequately prevented during the study?
Low risk of bias Any one of the following.
No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be in uenced by lack of blinding.
Blinding of participants and key study personnel ensured, an d unlikely that the blinding could have been broken.
Either participants or some key study personnel were not blin ded, but outcome assessment was blinded and the non-blinding o f others is unlikely to introduce bias. 96 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. High risk of bias Any one of the following. No blinding or incomplete blinding, and the outcome or outcome m easurement is likely to be in uenced by lack of blinding.
Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken.
Either participants or some key study personnel were not blin ded, and the non-blinding of others is likely to introduce bias.
Unclear Either of the following. Insuf cient information available to permit a judgement of l ow or high risk of bias.
The study did not address this outcome.
4. Were incomplete outcome data adequately addressed?
Low risk of bias Any one of the following. No missing outcome data.
Reasons for missing outcome data unlikely to be related to tru e outcome (for survival data, censoring unlikely to be introduci ng bias).
Missing outcome data balanced in numbers across intervention g roups, with similar reasons for missing data across groups.
For dichotomous outcome data, the proportion of missing outcom es compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate .
For continuous outcome data, plausible effect size (difference i n means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on obser ved effect size.
Missing data have been imputed using appropriate methods.
High risk of bias Any one of the following. Reason for missing outcome data likely to be related to true ou tcome, with imbalance in numbers or reasons for missing data across intervention groups. For dichotomous outcome data, the proportion of missing outcom es compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate. For continuous outcome data, plausible effect size (difference i n means or standardised difference in means) among missing outcomes enough to induce clinically relevant bias in observed e ffect size.
’As-treated’ analysis done with substantial departure of th e intervention received from that assigned at randomisation .
Potentially inappropriate application of simple imputatio n.
Unclear Either of the following. Insuf cient reporting of attrition/exclusions to permit jud gement of low or high risk of bias (e.g. number randomised not s tated, no reasons for missing data provided). The study did not address this outcome.
5. Are reports of the study free of the suggestion of selectiv e outcome reporting?
Low risk of bias Either of the following. 97 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. The study protocol is available and all of the study’s prespeci ed (primary and secondary) outcomes that are of interest in the review have been reported in the prespeci ed way.
The study protocol is not available but it is clear that the publ ished reports include all expected outcomes, including those th at were prespeci ed (convincing text of this nature may be uncommon).
High risk of bias Any one of the following. Not all of the study’s prespeci ed primary outcomes have been r eported.
One or more primary outcomes are reported using measurements , analysis methods or subsets of the data (e.g. subscales) that were not prespeci ed. One or more reported primary outcomes were not prespeci ed (unl ess clear justi cation for their reporting is provided, such as an unexpected adverse effect).
One or more outcomes of interest in the review are reported inco mpletely so that they cannot be entered in a meta-analysis.
The study report fails to include results for a key outcome that would be expected to have been reported for such a study.
Unclear Insuf cient information available to permit judgement of lo w or high risk of bias. It is likely that the majority of studies will fall into this category.
6. Other sources of potential bias Low risk of bias The study appears to be free of other sources of bias.
High risk of bias There is at least one important risk of bias. For example, the study:
had a potential source of bias related to the speci c study desi gn used; or has been claimed to have been fraudulent; or had some other problem.
Unclear There may be a risk of bias, but there is either: insuf cient information to assess whether an important risk of bias exists; or insuf cient rationale or evidence that an identi ed problem w ill introduce bias. 98 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. F E E D B A C K Enquiry about status of any ongoing trials, 11 August 2008 Summary The Authors conclusions’ include suggestions for trials that are needed. Ecolab Ltd would like to know if any of the trials hav e or are being carried out?
Submitter has modi ed con ict of interest statement: I certify that I have af liations with an organisation or entity with a nancial interest in the subject matter of my feedback.
Reply Tanner conducted a randomised controlled trial in April to June 2008 comparing nail brushes and nail picks with 164 operating r oom staff. This study found no difference in the number of colony fo rming units on the hands of the scrub staff one hour after they h ad scrubbed with antiseptic solution and a nail pick, antiseptic solution and a nail brush or antiseptic solution alone. The authors of this review have not been informed of other studies in this eld.
New searches have been conducted for this review which is currentl y being updated.
Contributors Author of feedback: Alex Haworth Occupation Business Developm ent Manager, Ecolab Ltd.
Review author: Judith Tanner W H A T ’ S N E W Last assessed as up-to-date: 10 June 2015.
Date Event Description 11 January 2016 New citation required but conclusions have not changed First update. New search. Four new trials. Conclusions unchanged 30 June 2015 New search has been performed Risk of bias updated, Grade assessment undertaken. Re- vision of Results to streamline text and introduction of new supporting table to replace text 99 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. H I S T O R Y Protocol rst published: Issue 3, 2003 Review rst published: Issue 1, 2008 Date Event Description 26 August 2008 Feedback has been incorporated Response to enquiry regarding the status of ongoing trials. 8 August 2008 Amended Converted to new review format. 4 October 2007 New citation required and conclusions have changed Substantive amendment C O N T R I B U T I O N S O F A U T H O R S Judith Tanner:conceived and designed the review; performed part of the data a nalysis and interpretation, writing and editing; made an intellectual contribution to and advised on the review; app roved the nal version before submission; performed previous work that was the foundation for the current review and wrote to study au thors/experts/companies.
Jo Dumville: extracted data; analysed and interpreted data and checked qual ity assessment; performed statistical analysis; completed the rst draft of the review, approved the nal version prior to submission and is the guarantor of the review.
Gill Norman: checked quality of data extraction and analysed and interprete d data; checked quality assessment; checked quality of statistical analysis; performed part of writing and editing the review; and approved the nal version before submission .
Matthew Fortnam: undertook quality assessment and approved the nal version before submission.
Contributions of the editorial base For this update:
Joan Webster and Nicky Cullum (Editors) edited the protocol, ad vised on methodology, interpretation and content; approvedthe nal review update prior to submission.
Sally Bell-Syer: co-ordinated the editorial process; advised o n content; Gill Rizzello: edited the review update.
Rocio Rodriguez: designed the search strategy, ran the searche s. Reetu Child edited the search methods section.
D E C L A R A T I O N S O F I N T E R E S T Judith Tanner:
Judith Tanner gave a lecture at two study days in 2013 for which h er employer was paid an honorarium from Molnlycke HealthCare.
Judith Tanner had no control of the funds. Molnlycke Healthcare produce a surgical hand antiseptic solution.
Judith Tanner gave a lecture at a study day in 2015 for which she w as paid an honorarium from Molnlycke HealthCare. This money was later forwarded to her employer and Judith Tanner has no co ntrol of the funds. Molnlycke Healthcare produce a surgical hand antiseptic solution.
Judith Tanner gave a lecture at a study day in 2015 for which she w as paid an honorarium from Smith and Nephew. Smith and Nephew do not make any products relevant to this review.
Jo Dumville: none known.
Gill Norman: my employment at the University of Manchester is funded by NIH R Cochrane programme Grant 13/89/08- High Priority Cochrane Reviews in Wound Prevention and Treatment . 100 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd. Matthew Fortnam:none known.
S O U R C E S O F S U P P O R T Internal sources University of Nottingham, UK.
School of Nursing, Midwifery and Social Work, University of Ma nchester, UK.
External sources National Institute for Health Research (NIHR), UK, UK.
This project was supported by the National Institute for Heal th Research, via Cochrane Infrastructure and Cochrane Programm e Grant funding (NIHR Cochrane Programme Grant 13/89/08 - High P riority Cochrane Reviews in Wound Prevention and Treatment) to Cochrane Wounds. The views and opinions expres sed therein are those of the authors and do not necessarily re ect those of the Systematic Reviews Programme, NIHR, NHS or the D epartment of Health.
D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W In this update we removed rates of septicaemia from the outcome s.
I N D E X T E R M S Medical Subject Headings (MeSH) General Surgery; Anti-Infective Agents, Local [ administration & dosage]; Antisepsis [ methods]; Colony Count, Microbial; Hand [ microbiology]; Hand Disinfection [ methods]; Randomized Controlled Trials as Topic; Surgical Wou nd Infection [epidemiology; prevention & control] MeSH check words Humans 101 Surgical hand antisepsis to reduce surgical site infection (Review) Copyright © 2016 The Cochrane Collaboration. Published by J ohn Wiley & Sons, Ltd.
