TITLE: Preoperative Skin Preparation: A Review of the Clinical Effectiveness and Guidelines

TITLE: Preoperative Skin Preparation: A Review of the Clinical Effectiveness and Guidelines DATE: 31 August 2010 CONTEXT AND POLICY ISSUES: A surgical site infection (SSI) is defined as an infection that occurs at a surgical site within 30 days of a surgery or within one year if the surgery involved implanting a foreign object such as a joint replacement. 1 Symptoms of a SSI may include purulent drainage, redness, pain, tenderness, swelling, and warmth at the surgical site. 1 The risk of developing a SSI can be increased by a number of factors, one of which is the level of endogenous contamination according to the classification of surgical wounds (appendix). 2 Surgical site infections occur in about 3% of surgeries overall, but range from 2% in clean surgical sites to 10% in dirty surgical sites. 3 While about 70% of SSIs are superficial skin infections, more serious infections involving tissues and organs can occur. 4 Surgical site infections are associated with increased morbidity for the patient and serious economic consequences to the health care system. 3 The average length of hospitalization for patients with SSIs is approximately 6.5 days longer than patients without SSIs. 3 Surgical protocols are designed to minimize the risk of surgical site infections and their associated consequences. 3 One component of a surgical protocol may involve preparation of the incision site with a topical antiseptic agent to reduce the microbial count on the skin. 3 Examples of topical antiseptic agents that are used as preoperative skin preparations include iodophors (povidone-iodine), alcohol-containing products, and chlorhexidine gluconate. 3 This report will review the evidence of clinical effectiveness and guidelines for use of preoperative topical antiseptic agents for the prevention of SSI in patients undergoing surgery. This information could be used to help inform policy decisions regarding institutional protocols and guidelines for preventing SSIs. Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

RESEARCH QUESTIONS: 1. What is the clinical effectiveness of preoperative skin preparations for the prevention of infections in patients undergoing surgery? 2. What are the guidelines and recommendations pertaining to the preoperative skin preparation for patients undergoing surgery? METHODS: A limited literature search was conducted on key health technology assessment resources, including PubMed, EBSCOhost CINAHL, The Cochrane Library (Issue 7, 2010) University of York Centre for Reviews and Dissemination (CRD) databases, ECRI (Health Devices Gold), EuroScan, international health technology agencies, and a focused Internet search. The search was limited to English language articles published between January 1, 2005 and August 3, 2010. No filters were applied to limit retrieval by study type. Health technology assessments, meta-analyses, systematic reviews and randomized controlled trials (RCTs) were eligible for inclusion if they involved patients undergoing skin anti-sepsis in hospital prior to surgery and reported rates of SSIs as an outcome. Studies that reported only bacterial counts following anti-sepsis were excluded. SUMMARY OF FINDINGS: Four relevant systematic reviews, 2,5-7 two RCTs, 8,9 and three evidence-based guidelines 2,10,11 were identified. One additional systematic review was identified, 12 but was a duplicate publication of one of the included systematic reviews. 6 Three additional relevant RCTs were identified, 13-15 but were included in one or more of the systematic reviews, so are not summarized individually in this rapid review. Systematic reviews and meta-analyses Webster et al (2009) conducted a systematic review to assess the effectiveness of preoperative bathing or showering with antiseptics for the prevention of SSIs. 5 RCTs were eligible for inclusion if they involved any group of patients undergoing surgery. Other study designs were not considered. The intervention of interest was any strength of antiseptic solution regimen used during a bath or shower prior to surgery. The comparators of interest were 1) non-antiseptic soap in a shower or bath or 2) no shower or bath. The primary outcome was the rate of SSI. Relevant literature was identified by electronic database searching, searching reference lists, and contacting manufacturers. A systematic approach to study selection, quality assessment, and data extraction was used. Seven RCTs were included in the systematic review. Six of the included studies specified that the intervention occurred in hospital. It was not clear where the intervention occurred for the seventh study. Three of the RCTs had two arms and four studies had three arms. Showering or bathing with chlorhexidine was compared to placebo detergent (4 studies; 7791 participants), bar soap (3 studies; 1443 participants), or no shower or bath (3 studies; 1142 participants). One study with 1093 participants compared two different chlorhexidine regimens (whole body Preoperative Skin Preparation 2

washing versus washing only the surgical site). For the comparison between chlorhexidine 4% and placebo detergent, the rate of SSIs was not statistically significantly different [relative risk (RR): 0.91; 95% confidence interval (CI): 0.80 to 1.04], nor was the rate of allergic reaction (RR: 0.89; 95% CI: 0.36 to 2.19). For the comparison between chlorhexidine 4% and bar soap, the difference in the rate of SSI was not statistically significant (RR: 1.02; 95% CI: 0.57 to 1.84). For the comparison between chlorhexidine and no shower or bath, studies were considered to be too heterogeneous to pool data. In two of the three unpooled studies, the reduction in rate of SSI with chlorhexidine was not statistically significant (n = 164 total). However, in the largest study (n = 978), the relative risk of SSI was reduced with chlorhexidine wash (RR 0.36; 95% CI 0.17 to 0.79). The comparison of whole versus partial body wash with chlorhexidine favoured whole body washing in terms of the relative risk of SSI (RR 0.40, 95% CI 0.19 to 0.85). The authors of the systematic review concluded that there was no clear evidence of benefit with showering or bathing preoperatively with chlorhexidine compared to other wash products in reducing the rate of SSIs. In 2008, the National Collaborating Centre for Women s and Children s Health conducted a systematic literature review as part of the process for developing guidelines for the prevention and treatment of SSIs. 2 The guideline was commissioned by the National Institute for Health and Clinical Excellence (NICE). A systematic approach to identification of relevant literature, data extraction, quality assessment, and data synthesis was briefly described in the report and it was stated that standard NICE methodology was used. All study designs were potentially eligible for inclusion, but the highest level of evidence available was used to answer each question. For example, evidence from observational studies would be considered in the absence of evidence from a systematic review, meta-analysis, or RCT. Two research questions from the NICE systematic review were relevant to this rapid review: What is the clinical effectiveness of preoperative showering to reduce surgical site infection? 2 and Is the use of preoperative skin antiseptics clinically effective in the prevention of surgical site infection? 2 The NICE literature review identified an earlier version of the systematic review by Webster et al (2009). 5 This version was published in 2008 and, therefore, only included six RCTs (n = 10,007) as opposed to seven. The NICE systematic review pooled data to create a comparison of preoperative showering or bathing with 4% chlorhexidine solution to placebo detergent or bar soap (two different comparators were combined). This comparison involved five RCTs with a total of 8445 participants. The reduction in the risk of SSI was not statistically significant (RR 0.90; 95% CI: 0.79 to 1.02). According to the NICE summary, there were two studies of showering with 4% chlorhexidine versus no showering, one of which found a statistically significant reduction in the rate of SSI with chlorhexidine showering (n = 978), but the other study did not (n = 64). Related evidence statements were made and are summarized in the guidelines section that follows in this rapid review. One relevant Cochrane systematic review (six trials, 2850 participants) and four additional RCTs were included in the NICE systematic review to address the question of the clinical effectiveness of preoperative skin antiseptics. The trials included patients undergoing nonlaparoscopic abdominal surgery, elective laparotomy and coronary artery bypass graft. Iodinebased antiseptics, chlorhexidine and alcohol were investigated in the studies. The included Cochrane systematic review reported results from two studies (n = 94 and n = 200) that involved comparisons of iodophol-in-alcohol (a film-forming, water-insoluble antiseptic) to aqueous iodophor scrub and paint. Results of the two studies were not pooled and no statistically Preoperative Skin Preparation 3

significant differences in SSI risk were found in either study. The remaining four studies from the Cochrane review were not considered relevant to the research question posed in the NICE report. The four additional RCTs compared different antiseptic regimens. One study involved a head-tohead comparison of five different regimens: chlorhexidine in alcohol, 2% iodine in three different concentrations of alcohol and 70% alcohol alone (n = 70). The second study compared chlorhexidine in 70% alcohol administered via a spray to scrubbing with iodine soap followed by painting with povidone-iodine paint (n = 737). A third study compared one minute of scrubbing with a solution of 70% alcohol to one minute of scrubbing with chlorhexidine in alcohol (n = 73). A fourth study compared alcohol to iodine in alcohol (n = 311). No statistically significant differences between treatment arms in the risk of SSI were found in any of the four studies. The available evidence was considered insufficient to make any conclusions about the comparative efficacy of the three antiseptics for the prevention of SSI. This conclusion appeared to relate to lack of power or low quality of the individual studies, as outlined in the guidelines section that follows. This systematic review appeared to be methodologically rigorous, but was limited by the quality of the available evidence. A 2007 systematic review compared the clinical effectiveness of chlorhexidine and povidoneiodine as skin antiseptics in patients undergoing surgery, in patients undergoing insertion of vascular or epidural catheters, and for the prevention of contamination of blood cultures. 7 Limited details of the systematic review methodology were provided, but evidence was identified from systematic literature searches and underwent quality assessment. Prospective, randomized and non-randomized controlled trials were eligible for inclusion. One RCT (n = 371) was identified that compared the efficacy of chlorhexidine 0.5% in spirit to povidone-iodine 10% in alcohol as preoperative antiseptics and reported the rate of SSI. Patients in the RCT were undergoing elective surgery and had clean surgical wounds. Wound infection was assessed at discharge. The relative risk of SSI was 0.26 (95% CI: 0.12 to 0.55), which indicated a lower rate of SSI in the chlorhexidine group. The report did not include any conclusions or recommendations. Limitations to this systematic review include the lack of detail about the methodology, which makes it difficult to assess the rigor of the review. The one included study was from 1982, so it is not clear if its results would be generalizable to the present given changes in surgical protocols, surgical procedures, and microbial resistance patterns. A 2006 systematic review and meta-analysis was conducted to assess the efficacy of antimicrobial therapy, preoperative skin antiseptics and wound management in preventing SSIs in patients undergoing peripheral arterial reconstruction. 6 Any intervention that was performed in an attempt to reduce or prevent infection in arterial surgery was considered relevant to the research question. Outcomes of interest were rates of SSIs, based upon positive culture results or clinical signs of infection. RCTs were included in the review. Electronic database searching and hand searching was used to identify the relevant literature. A systematic approach to study selection, quality assessment and data extraction was used. Three RCTs (n = 3610) were included which assessed the efficacy of skin antiseptics. In two studies chlorhexidine was used as either as an undiluted paint all over the body and rinsed off in Preoperative Skin Preparation 4

a bath twice prior to surgery or as a shower with 4% chlorhexidine three times preoperatively. Non-medicated soap and detergent were used as comparators in these studies. In one study povidone-iodine was painted on the skin twice daily from nipple to knees for two days prior to surgery and was compared to a control (which was defined as no povidone-iodine). It was not clear if all preoperative preparation occurred in hospital. The pooled relative risk of SSI from the three studies was 0.97 (95% CI: 0.70 to 1.36). Based on these studies, the authors concluded that there was no evidence that bathing or showering preoperatively with antiseptic agents conferred any benefit in reducing the risk of SSI. One potential limitation of this systematic review was that the identified studies were published between 1989 and 1993. Changes in antimicrobial resistance patterns over time could affect the generalizability of the findings. As well, this systematic review was restricted to patients undergoing peripheral artery reconstruction, so it is not clear if the results would be applicable to other surgeries. Randomized controlled trials An RCT published in 2010 was carried out to compare the efficacy of 2% chlorhexidine with 70% alcohol (n = 409) and 10% povidone iodine (n = 440) for the prevention of SSIs. 8 The study was carried out in the United States at six university hospitals. Adult patients undergoing clean-contaminated surgery were eligible for inclusion. Clean-contaminated surgery was defined as colorectal, small intestinal, gastroesophageal, biliary, thoracic, gynecologic, or urologic operations performed under controlled conditions without substantial spillage or unusual contamination. 8 Patients with allergies to the antiseptics, who had evidence of infection at or near the surgical site and who could not be followed for 30 days after surgery were excluded. Patients were randomly assigned to undergo preoperative scrub with an applicator containing chorhexidine with alcohol or preoperative scrub, followed by paint with the aqueous iodine solution. It was not clear how long prior to surgery that antisepsis was performed. All patients received systemic antibiotics prior to surgery and approximately one-half received systemic antibiotics post-operatively. The primary outcome measure of the study was the rate of SSI after 30 days of follow-up. Rates of specific categories of SSIs were the secondary outcomes. Centers for Disease Control (CDC) criteria were used to define SSI. 1 At the end of follow-up, 9.5% of patients in the chlorhexidine group and 16.1% of the povidone iodine group developed surgical site infections (RR: 0.59; 95% CI: 0.41 to 0.85; p = 0.004). The risk of superficial incisional infections (RR: 0.48; 95% CI: 0.28 to 0.84) was lower with chlorhexidine. The differences between groups in the risk of deep incisional infections (RR: 0.33; 95% CI: 0.11 to 1.01), organ-space infection (RR: 0.97; 95% CI, 0.52 to 1.80) or sepsis from surgical-site infection (RR: 0.62; 95% CI, 0.30 to 1.29) were not statistically significant. Rates of adverse events were similar between the two treatment arms. The authors of the study concluded that optimal skin antisepsis prior to surgery could confer a significant clinical benefit and that chlorhexidine alcohol was superior to povidone iodine for the prevention of SSI after clean-contaminated surgery. One limitation to this study was that the precise technique of skin antisepsis (e.g., timing of application prior to surgery, duration of application) was not sufficiently described in the report to allow for replication. Further, the operating surgeon was aware of the treatment group. It was stated that the investigator who evaluated adverse events was blinded to treatment group, but it was not clear if this would include ascertainment of SSIs. This study was performed in individuals with clean-contaminated wounds. It is not clear if similar results would be expected in patients with other wound categories. Preoperative Skin Preparation 5

A 2009 RCT compared the efficacy of chlorhexidine 4% and povidone-iodine in the prevention of surgical site infections. 9 The study was carried out at a university hospital in Thailand. Patients undergoing surgery were included if they were between the ages of 18 and 60 years, had clean, clean contaminated or contaminated wounds and were ASA class 1 and 2 (these categories were not further defined, but ASA categorization is a rating system used to assess the fitness of patients undergoing surgery). Patients with dirty wounds were excluded, as were patients with uncontrolled diabetes, those on immunosuppressants, who had serum albumin < 3.0 mg/dl, or had allergies to either antiseptic. Patients were randomly assigned to either a five minute scrub with povidone-iodine scrub solution, followed by povidone-iodine paint (n = 250) or a five minute scrub with 4% chlorhexidine in 70% alcohol followed by chlorhexidine paint (n = 250). The rate of SSI was determined up to 30 days following surgery, with a SSI defined as a surgical wound that drained purulent material or was judged by a surgeon to be infected and was subsequently opened. Approximately 3.2% of the povidone-iodine group developed SSIs, compared to 2.0% of the chlorhexidine group (RR: 1.61; 95% CI: 1.40 to 1.81). Two patients in the povidone-iodine group experienced skin irritation compared to none in the chlorhexidine group. The authors concluded that the rate of post-operative SSI was lower with chlorhexidine and that it should be considered first-line for preoperative skin preparation. Limitations to this study included a lack of clarity as to whether the individuals assessing outcomes were blinded to treatment status and potentially subjective criteria for the ascertainment of SSI. Guidelines and recommendations In 2009, the Institute for Clinical Systems Improvement produced a perioperative protocol. 10 The methodology for the development of the protocol was not described, but the level of evidence to support statements was provided. Regarding preoperative skin antisepsis the following statement was made: There is insufficient evidence from randomized trials to support the use of antiseptic preparation of the skin, or of one antiseptic over another. 10 This statement was supported by M-level evidence, defined as either meta-analysis, systematic review, decision analysis, or cost-effectiveness analysis. In 2008 the National Collaborating Centre for Women s and Children s Health developed a guideline for the prevention of surgical site infections. 2 The guideline was developed by a multidisciplinary group that included surgeons, nurses, microbiologists, infection control specialists and lay people. Guidelines were based upon systematic searches and critical appraisal of the literature, in accordance with NICE s standard methodology. Details of the systematic review were summarized previously in this rapid review. Statements were graded according to the risk of bias. The following statements were made regarding the use of antiseptics prior to surgery: There is evidence from a single quasi-rct that there is no difference in SSI rate with or without an antiseptic for clean surgery in an outpatient setting. [EL = 1 ] There is evidence from one RCT that shows no difference in SSI rate between preoperative skin preparation with alcohol-based chlorhexidine spray or iodine soap/aqueous povidone-iodine paint. [EL = 1+] There is insufficient evidence from one underpowered RCT to establish whether there is any difference in SSI rate following preoperative skin preparation with chlorhexidine or alcohol. [EL = Preoperative Skin Preparation 6

1+] There is insufficient evidence from one underpowered RCT to establish whether there are any differences in SSI rate following preoperative skin preparation with 2% iodine in 50%, 70% or 90% alcohol. [EL = 1+] There is insufficient evidence from a single quasi-rct to determine whether preoperative skin preparation with aqueous iodine or iodine in alcohol affects the rate of SSI. [EL = 1 ] There is insufficient evidence to demonstrate any difference on SSI rate of adding free iodine to an alcohol-based scrub solution or using alcohol as a preoperative skin preparation. [EL = 1+] There is insufficient evidence to demonstrate any difference on SSI rate of using an iodophor-inalcohol, film-forming, water-insoluble antiseptic compared with an aqueous iodophor scrub and paint for preoperative skin preparation. [EL = 1+] There is evidence from meta-analysis of two RCTs that there is no difference in SSI rate following preoperative skin preparation by scrubbing and painting or painting alone with an aqueous solution of povidone-iodine. [EL = 1+] (p 59-60) 2 Level 1+ evidence came from well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias, whereas level 1- evidence came from meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias. Based this evidence, it was recommended that the skin at the surgical site be prepared with an appropriate antiseptic (povidone-iodine or chlorhexidine) immediately prior to the surgical incision. The following statements were made regarding preoperative showering: There is evidence from one RCT that showering or bathing using chlorhexidine significantly reduces the rate of SSI compared with no showering. [EL = 1+] There is evidence of no difference in SSI incidence when chlorhexidine or detergent/bar soap is used for preoperative showering or bathing. [EL = 1+] There is no (systematic review or RCT) evidence that examines the clinical effectiveness of the timing or number of preoperative showers to prevent SSI. (p 24-25) 2 Based on this evidence, it was recommended that patients shower, bath or bed-bath (with assistance if needed) with soap either on of the day of or the day prior to surgery. In 2008, the Betsy Lehman Center for Patient Safety and Medical Error Reduction and Massachusetts Department of Public Health developed expert panel recommendations on the prevention of health-care associated infections, which included SSIs. 11 Recommendations were based upon evidence identified through systematic literature searches and developed through a consensus-based approach. Levels of evidence with strength of recommendation were provided. The following recommendations regarding anti-sepsis prior to surgery were made: 7. Preoperative showering or bathing with agents such as chlorhexidine has been shown to reduce bacterial colonization of the skin but has not definitively been proven to decrease SSI risk. If hospitals elect to use preoperative showering with chlorhexidine soap as an SSI strategy, staff responsible for presurgical evaluations shall educate patients on the appropriate showering Preoperative Skin Preparation 7

technique. UI 8. Thoroughly wash and clean at and around the incision site to remove gross contamination before performing antiseptic skin preparation. A-IV 9. Use an appropriate antiseptic agent for skin preparation. A-IV 10. Apply preoperative antiseptic skin preparation using manufacturer s product guidelines. The prepared area must be large enough to extend the incision or create new incisions or drain sites, if necessary. A-IV (p 61-62) 2 A rating of UI was an unresolved issue, and A-IV was a strong recommendation that was supported by opinion, clinical evidence or reports of expert committees. Limitations Four relevant systematic reviews, 2,5-7 and two additional RCTs 8,9 provided evidence of the clinical effectiveness of skin antiseptics prior to surgery. Three systematic reviews 2,5,6 appeared to be rigorous in their conduct, but the included studies had limitations such as poor description of the interventions, lack of blinding of the surgeon or individual assessing outcomes, and a low event rate. For some of the included studies, the sample sizes of the individual treatment arms were difficult to determine. Often precise concentrations of the antiseptic agents and method of application were not provided in the systematic review, which would make the experimental conditions difficult to replicate in real-world settings. Further, much of the literature included in the systematic reviews was conducted in the 1980 s and 1990 s. 2,5-7 It is not clear if similar results would be expected in the present time given changes in microbial resistance patterns overtime, surgical procedures and protocols, institutional policies, and the pathogens most likely to be encountered. Moreover, it would be difficult to determine the generalizability of the results from individual studies given that skin antisepsis would be one component of a larger institutional protocol. The two additional RCTs provide more recent evidence of the comparative efficacy of chlorhexidine and povidone-iodine, but similar generalizability issues could exist (e.g., changes in microbial resistance patterns or surgical protocols). One of the two RCTs did not use an objective or standard definition of SSI 9 and neither RCT assessed the SSI rate beyond 30 days. 8,9 The 30 day follow-up, however, would not be considered a limitation if none of the surgeries involved implantation of a foreign object, but it was not clear if these types of surgeries were included. Three evidence-based guidelines were identified, none of which was Canadian, but could be applicable to the Canadian context given that two were conducted in the United States 10,11 and one in the United Kingdom. 2 A common theme in these guidelines was that the evidence was too limited, insufficient or flawed to recommend one antiseptic over the other. CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING: Bathing or showering with chlorhexidine prior to surgery was not found to reduce the rate of SSI. This was observed in one systematic review that included studies of patients undergoing any surgical intervention and in one systematic review that included only patients undergoing peripheral arterial reconstruction. One guideline addressed preoperative showering and recommended that soap be used either on the day of or the day prior to surgery. Thus, the Preoperative Skin Preparation 8

evidence included in this rapid review does not provide clear evidence that the use of chlorhexidine during showering or bathing prior to surgery is more effective in reducing the risk of SSI than showering with bar soap or placebo detergent. No other antiseptics were studied in this regard. Two systematic reviews assessed preoperative skin antisepsis with chlorhexidine and povidoneiodine. One systematic review indicated that there was insufficient evidence to make any conclusions about the comparative efficacy of the three antiseptics (chlorhexidine, povidoneiodine and alcohol) for the prevention of SSI. This conclusion is echoed in evidence-based guidelines that do not endorse one antiseptic over another. The other systematic review found that chlorhexidine was superior to povidone-iodine, but this systematic review included only one study from 1982. Evidence from two recent RCTs (published in 2009 and 2010) suggest a decreased risk of SSI with chlorhexidine compared to povidone-iodine. Given that there are conflicting results between earlier systematic reviews and more recent RCTs, an updated systematic review incorporating all of the available evidence would better answer the question of clinical effectiveness of preoperative antiseptics for the prevention of infections in patients undergoing surgery. PREPARED BY: Health Technology Inquiry Service Email: htis@cadth.ca Tel: 1-866-898-8439 Preoperative Skin Preparation 9

REFERENCES: 1. Horan TC, Andrus M, Dudek MA. CDC/NHSN surveillance definition of health careassociated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control [Internet]. 2008 [cited 2010 Aug 3];36(5):309-32. Available from: http://www.cdc.gov/ncidod/dhqp/pdf/nnis/nosinfdefinitions.pdf 2. National Collaborating Centre for Women's and Children's Health. Surgical site infection: prevention and treatment of surgical site infection [Internet]. London: National Institute for Health and Clinical Excellence (NICE); 2008 Oct. (Clinical Guideline). [cited 2010 Aug 3]. Available from: http://www.nice.org.uk/nicemedia/live/11743/42378/42378.pdf 3. Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev [Internet]. 2004 [cited 2010 Aug 3];(3):CD003949. Available from: http://www.thecochranelibrary.com/view/0/index.html Subscription required. 4. Centers for disease control and prevention [Internet]. Atlanta (GA): Centers for Disease Control and Prevention; 2010. Surgical site infection (SSI); 2008 Dec 17 [cited 2010 Aug 3]. Available from: http://www.cdc.gov/ncidod/dhqp/faq_ssi.html 5. Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev [Internet]. 2007 [cited 2010 Aug 3];(2):CD004985. Available from: http://www.thecochranelibrary.com/view/0/index.html Subscription required. 6. Stewart A, Eyers PS, Earnshaw JJ. Prevention of infection in arterial reconstruction. Cochrane Database Syst Rev [Internet]. 2006 [cited 2010 Aug 3];(3):CD003073. Available from: http://www.thecochranelibrary.com/view/0/index.html Subscription required. 7. Agarwal R, Miller J, Fishman N, Bassoline B, Rohrbach J, Umscheid CA, et al. Skin antiseptics to prevent surgical site infections. Philadelphia (PA): Center for Evidencebased Practice (CEP); 2009 Nov 4. 8. Darouiche RO, Wall MJ, Jr., Itani KM, Otterson MF, Webb AL, Carrick MM, et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. 9. Paocharoen V, Mingmalairak C, Apisarnthanarak A. Comparison of surgical wound infection after preoperative skin preparation with 4% chlorhexidine [correction of chlohexidine] and povidone iodine: a prospective randomized trial. J Med Assoc Thai. 2009 Jul;92(7):898-902. 10. Health care protocol: perioperative protocol [Internet]. 2nd ed. Bloomington (MN): Institute for Clinical Systems Improvement; 2009 Sep. 102 p. [cited 2010 Aug 3]. Available from: http://www.icsi.org/perioperative protocol 36011/perioperative protocol.html 11. Prevention and control of healthcare-associated infections in Massachusetts [Internet]. Boston (MA): JSI Research and Training Institute; 2008 Jan 31. 151 p. [cited 2010 Aug 3]. Preoperative Skin Preparation 10

Available from: http://www.mass.gov/eeohhs2/docs/dph/patient_safety/haipcp_final_report_pt1.pdf 12. Stewart AH, Eyers PS, Earnshaw JJ. Prevention of infection in peripheral arterial reconstruction: a systematic review and meta-analysis. J Vasc Surg. 2007;46(1):148-55. 13. Veiga DF, Damasceno CA, Veiga-Filho J, Figueiras RG, Vieira RB, Garcia ES, et al. Randomized controlled trial of the effectiveness of chlorhexidine showers before elective plastic surgical procedures. Infect Control Hosp Epidemiol [Internet]. 2009 Jan [cited 2010 Aug 3];30(1):77-9. Available from: http://www.journals.uchicago.edu/doi/pdf/10.1086/592980 14. Ellenhorn JD, Smith DD, Schwarz RE, Kawachi MH, Wilson TG, McGonigle KF, et al. Paint-only is equivalent to scrub-and-paint in preoperative preparation of abdominal surgery sites. J Am Coll Surg. 2005 Nov;201(5):737-41. 15. Kalantar-Hormozi AJ, Davami B. No need for preoperative antiseptics in elective outpatient plastic surgical operations: a prospective study. Plast Reconstr Surg. 2005 Aug;116(2):529-31. Preoperative Skin Preparation 11

APPENDIX: CLASSIFICATION OF SURGICAL WOUNDS 2 Clean an incision in which no inflammation is encountered in a surgical procedure, without a break in sterile technique, and during which the respiratory, alimentary and genitourinary tracts are not entered. Clean-contaminated an incision through which the respiratory, alimentary or genitourinary tract is entered under controlled conditions but with no contamination encountered. Contaminated an incision undertaken during an operation in which there is a major break in sterile technique or gross spillage from the gastrointestinal tract, or an incision in which acute, non-purulent inflammation is encountered. Open traumatic wounds that are more than 12 24 hours old also fall into this category. Dirty or infected an incision undertaken during an operation in which the viscera are perforated or when acute inflammation with pus is encountered during the operation (for example, emergency surgery for faecal peritonitis), and for traumatic wounds where treatment is delayed, and there is faecal contamination or devitalised tissue present. p. XX 2 Preoperative Skin Preparation 12