General Guideline Title Global guidelines for the prevention of surgical site infection. Bibliographic Source(s) World Health Organization (WHO). Global guidelines for the prevention of surgical site infection. Geneva: World Health Organization (WHO); 2016. 184 p. [777 references] Guideline Status This is the current release of the guideline. This guideline meets NGC's 2013 (revised) inclusion criteria. NEATS Assessment National Guideline Clearinghouse (NGC) has assessed this guideline's adherence to standards of trustworthiness, derived from the Institute of Medicine's report Clinical Practice Guidelines We Can Trust. = Poor = Fair = Good = Very Good = Excellent Assessment Standard of Trustworthiness Disclosure of Guideline Funding Source YES Disclosure and Management of Financial Conflict of Interests Guideline Development Group Composition YES Multidisciplinary Group YES Methodologist Involvement Patient and Public Perspectives Use of a Systematic Review of Evidence Search Strategy Study Selection Synthesis of Evidence Evidence Foundations for and Rating Strength of Recommendations Grading the Quality or Strength of Evidence Benefits and Harms of Recommendations Evidence Summary Supporting Recommendations Rating the Strength of Recommendations Specific and Unambiguous Articulation of Recommendations External Review Updating Recommendations Major Recommendations Definitions for the strength of the recommendations (strong, conditional) and the quality of evidence (high, moderate, low, very low) are provided at the end of the "Major Recommendations" field. Preoperative Measures Preoperative Bathing It is good clinical practice for patients to bathe or shower prior to surgery. The panel suggests that either a plain or antimicrobial soap may be used for this purpose. (Conditional recommendation, moderate quality of evidence) The panel decided not to formulate a recommendation on the use of chlorhexidine gluconate (CHG)- impregnated cloths for the purpose of reducing surgical site infection (SSI) due to the limited and very low quality evidence. See Table 4.1.1 in the original guideline document for recommendations on preoperative bathing according to available guidelines. Decolonization with Mupirocin Ointment with or without Chlorhexidine Gluconate Body Wash for the Prevention of Staphylococcus aureus Infection in Nasal Carriers Undergoing Surgery The panel recommends that patients undergoing cardiothoracic and orthopaedic surgery with known nasal carriage of Staphylococcus aureus (S. aureus) should receive perioperative intranasal applications of mupirocin 2% ointment with or without a combination of CHG body wash. (Strong recommendation, moderate quality of evidence) The panel suggests considering to treat also patients with known nasal carriage of S. aureus undergoing other types of surgery with perioperative intranasal applications of mupirocin 2% ointment with or without a combination of CHG body wash. (Conditional recommendation, moderate quality of evidence) See Table 4.2.1 in the original guideline document for recommendations on screening and decolonization of S. aureus according to available guidelines and bundles. Screening for Extended-Spectrum Beta-lactamase Colonization and the Impact on Surgical Antibiotic Prophylaxis The panel decided not to formulate a recommendation due to the lack of evidence. Optimal Timing for Preoperative Surgical Antibiotic Prophylaxis The panel recommends the administration of surgical antibiotic prophylaxis (SAP) prior to the surgical incision when indicated (depending on the type of operation). (Strong recommendation, low quality of evidence) The panel recommends the administration of SAP within 120 minutes before incision, while considering the half-life of the antibiotic. (Strong recommendation, moderate quality of evidence) See Table 4.4.1 in the original guideline document for recommendations on SAP according to available guidelines. Mechanical Bowel Preparation and the Use of Oral Antibiotics The panel suggests that preoperative oral antibiotics combined with mechanical bowel preparation (MBP) should be used to reduce the risk of SSI in adult patients undergoing elective colorectal surgery. (Conditional recommendation, moderate quality evidence) The panel recommends that MBP alone (without administration of oral antibiotics) should not be used for the purpose of reducing SSI in adult patients undergoing elective colorectal surgery. (Strong recommendation, moderate quality evidence) See Table 4.5.1 in the original guideline document for recommendations on MBP and the administration of oral antimicrobials according to available guidelines. Hair Removal The panel recommends that in patients undergoing any surgical procedure, hair should either not be removed or, if absolutely necessary, it should be removed only with a clipper. Shaving is strongly discouraged at all times, whether preoperatively or in the operating room (OR). (Strong recommendation, moderate quality of evidence) See Table 4.6.1 in the original guideline document for recommendations on hair removal according to available guidelines. Surgical Site Preparation The panel recommends alcohol-based antiseptic solutions based on CHG for surgical site skin preparation in patients undergoing surgical procedures. (Strong recommendation, low to moderate quality of evidence) See Table 4.7.1 in the original guideline document for recommendations on surgical site skin preparation according to available guidelines. Antimicrobial Skin Sealants The panel suggests that antimicrobial sealants should not be used after surgical site skin preparation for the purpose of reducing SSI. (Conditional recommendation, very low quality of evidence) Surgical Hand Preparation The panel recommends that surgical hand preparation be performed either by scrubbing with a suitable antimicrobial soap and water or using a suitable alcohol-based handscrub (ABHR) before donning sterile gloves. (Strong recommendation, moderate quality of evidence) See Table 4.9.1 in the original guideline document for recommendations on surgical hand preparation according to available guidelines. Preoperative and/or Intraoperative Measures Enhanced Nutritional Support The panel suggests considering the administration of oral or enteral multiple nutrient-enhanced nutritional formulas for the purpose of preventing SSI in underweight patients who undergo major surgical operations. (Conditional recommendation, very low quality of evidence) Perioperative Discontinuation of Immunosuppressive Agents The panel suggests not discontinuing immunosuppressive medication prior to surgery for the purpose of preventing SSI. (Conditional recommendation, very low quality of evidence) Perioperative Oxygenation The panel recommends that adult patients undergoing general anaesthesia with endotracheal intubation for surgical procedures should receive an 80% fraction of inspired oxygen (FiO ) intraoperatively and, if 2 feasible, in the immediate postoperative period for 2 to 6 hours to reduce the risk of SSI. (Strong recommendation, moderate quality of evidence) See Table 4.12.1 in the original guideline document for recommendations on oxygenation preparation according to available guidelines. Maintaining Normal Body Temperature (Normothermia) The panel suggests the use of warming devices in the operating room and during the surgical procedure for patient body warming with the purpose of reducing SSI. (Conditional recommendation, moderate quality of evidence) See Table 4.13.1 in the original guideline document for recommendations on body temperature control (normothermia) according to available guidelines. Use of Protocols for Intensive Perioperative Blood Glucose Control The panel suggests the use of protocols for intensive perioperative blood glucose control for both diabetic and non-diabetic adult patients undergoing surgical procedures to reduce the risk of SSI. (Conditional recommendation, low quality of evidence) See Table 4.14.1 in the original guideline document for recommendations on perioperative blood glucose control according to available guidelines. Maintenance of Adequate Circulating Volume Control/Normovolemia The panel suggests the use of goal-directed fluid therapy (GDFT) intraoperatively to reduce the risk of SSI. (Conditional recommendation, low quality of evidence) See Table 4.15.1 in the original guideline document for recommendations on the maintenance of normovolemia according to available guidelines. Drapes and Gowns The panel suggests that either sterile, disposable, non-woven or sterile, reusable woven drapes and surgical gowns can be used during surgical operations for the purpose of preventing SSI. (Conditional recommendation, moderate to very low quality of evidence) The panel suggests not to use plastic adhesive incise drapes with or without antimicrobial properties for the purpose of preventing SSI. (Conditional recommendation, low to very low quality of evidence) Wound Protector Devices The panel suggests considering the use of wound protector (WP) devices in clean-contaminated, contaminated and dirty abdominal surgical procedures for the purpose of reducing the rate of SSI. (Conditional recommendation, very low quality of evidence) See Table 4.17.1 in the original guideline document for recommendations on the use of wound protector (WP) devices according to available guidelines. Incisional Wound Irrigation The panel considers that there is insufficient evidence to recommend for or against saline irrigation of incisional wounds before closure for the purpose of preventing SSI. The panel suggests considering the use of irrigation of the incisional wound with an aqueous povidone- iodine (PVP-I) solution before closure for the purpose of preventing SSI, particularly in clean and clean- contaminated wounds. The panel suggests that antibiotic incisional wound irrigation before closure should not be used for the purpose of preventing SSI. (Conditional recommendations, low quality of evidence) See Table 4.18.1 in the original guideline document for recommendations on wound irrigation according to available guidelines. Prophylactic Negative Pressure Wound Therapy The panel suggests the use of prophylactic negative pressure wound therapy (pNPWT) in adult patients on primarily closed surgical incisions in high-risk wounds, for the purpose of the prevention of SSI, while taking resources into account. (Conditional recommendation, low quality of evidence) Use of Surgical Gloves The panel decided not to formulate a recommendation due to the lack of evidence to assess whether double-gloving or changing of gloves during the operation or using specific types of gloves is more effective in reducing the risk of SSI. See Table 4.20.1 in the original guideline document for recommendations on gloving according to available guidelines. Changing of Surgical Instruments The panel decided not to formulate a recommendation on this topic due to the lack of evidence. Antimicrobial-Coated Sutures The panel suggests the use of triclosan-coated sutures for the purpose of reducing the risk of SSI, independent of the type of surgery. (Conditional recommendation, moderate quality of evidence) See Table 4.22.1 in the original guideline document for recommendations on the use of antimicrobial- coated sutures according to available guidelines. Laminar Airflow Ventilation Systems in the Context of Operating Room Ventilation The panel suggests that laminar airflow ventilation systems should not be used to reduce the risk of SSI for patients undergoing total arthroplasty surgery. (Conditional recommendation, low to very low quality of evidence) See Table 4.23.1 in the original guideline document for recommendations on ventilation systems in the operating room according to available guidelines. Postoperative Measures Surgical Antibiotic Prophylaxis Prolongation The panel recommends against the prolongation of SAP administration after completion of the operation for the purpose of preventing SSI. (Strong recommendation, moderate quality of evidence) See Table 4.24.1 in the original guideline document for recommendations on SAP according to available guidelines. Advanced Dressings The panel suggests not using any type of advanced dressing over a standard dressing on primarily closed surgical wounds for the purpose of preventing SSI. (Conditional recommendation, low quality of evidence) Antimicrobial Prophylaxis in the Presence of a Drain and Optimal Timing for Wound Drain Removal The panel suggests that perioperative antibiotic prophylaxis should not be continued to the presence of a wound drain for the purpose of preventing SSI. (Conditional recommendation, low quality of evidence) The panel suggests removing the wound drain when clinically indicated. No evidence was found to recommend an optimal timing of wound drain removal for the purpose of preventing SSI. (Conditional recommendation, very low quality of evidence) Definitions Grading of Recommendations Assessment, Development and Evaluation (GRADE) Categories of Quality of Evidence High: The panel is very confident that the true effect lies close to that of the estimate of the effect. Moderate: The panel is moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low: The panel's confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low: The panel has very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of the effect. Strength of Recommendations Strong: With strong recommendations, the guideline communicates the message that the desirable effects of adherence to the recommendation outweigh the undesirable effects. This means that in most situations the recommendation can be adopted as policy. Conditional: These are made when there is greater uncertainty about quality of evidence, balance of benefit versus harms and burdens, values and preferences, and resource use, or if local adaptation has to account for a greater variety in values and preferences, or when resource use makes the intervention suitable for some, but not for other locations. This means that there is a need for substantial debate and involvement of stakeholders before this recommendation can be adopted as policy. Clinical Algorithm(s) None provided Scope Disease/Condition(s) Surgical site infection (SSI) Guideline Category Management Prevention Risk Assessment Clinical Specialty Infectious Diseases Preventive Medicine Surgery Intended Users Advanced Practice Nurses Allied Health Personnel Health Care Providers Hospitals Nurses Pharmacists Physician Assistants Physicians Utilization Management Guideline Objective(s) To provide a comprehensive range of evidence-based recommendations for interventions to be applied during the pre-, intra- and postoperative periods for the prevention of surgical site infection (SSI), while taking into consideration resource availability and values and preferences Target Population Patients of any age undergoing any surgical procedure Note: There are recommendations that are either not proven for the paediatric population due to lack of evidence or inapplicable. Interventions and Practices Considered 1. Preoperative measures Preoperative bathing Decolonization with mupirocin ointment with or without chlorhexidine gluconate body wash for the prevention of Staphylococcus aureus infection in nasal carriers Optimal timing for preoperative surgical antibiotic prophylaxis Mechanical bowel preparation with or without oral antibiotics Hair removal (not recommended) Surgical site preparation (alcohol-based antiseptic solutions versus aqueous solutions) Antimicrobial skin sealants (not recommended) Surgical hand preparation 2. Preoperative and/or intraoperative measures Enhanced nutritional support Perioperative discontinuation of immunosuppressive agents (not recommended) Perioperative use of an increased fraction of inspired oxygen Maintaining normal body temperature (normothermia) Use of protocols for intensive perioperative blood glucose control Maintenance of adequate circulating volume control/normovolemia Use of drapes and gowns Wound protector devices Incisional wound irrigation Prophylactic negative pressure wound therapy Antimicrobial-coated sutures Laminar airflow ventilation systems in the context of operating room ventilation 3. Postoperative measures Prolongation of surgical antibiotic prophylaxis (recommendation against) Advanced dressings (not recommended) Antimicrobial prophylaxis in the presence of a drain (not recommended) Note: The following were considered but no recommendation was made because of lack of evidence: screening for extended-spectrum beta-lactamase colonization and the impact on antibiotic prophylaxis, use of surgical gloves (double gloving, changing gloves, type of gloves), changing of surgical instruments, optimal timing for wound drain removal. Major Outcomes Considered Surgical site infection (SSI) incidence rates SSI-attributable mortality Adverse effects of interventions Cost-effectiveness Methodology Methods Used to Collect/Select the Evidence Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence Evidence Identification and Retrieval The Systematic Reviews Expert Group (SREG) retrieved evidence on the effectiveness of interventions for the prevention of surgical site infection (SSI) from randomized controlled trials (RCTs) and nonrandomized studies as needed. The Guideline Steering Group provided the SREG with the methodology and a briefing on the desired output of the systematic reviews and the members of these groups agreed together on the format and timelines for reporting. Using the assembled list of priority topics, questions and critical outcomes from the scoping exercise identified by the World Health Organization (WHO) Guideline Steering Group, the Guideline Development Group (GDG) and the guideline methodologist, the SREG conducted 27 systematic reviews between December 2013 and October 2015 to provide the supporting evidence for the development of the recommendations. To identify relevant studies, systematic searches of various electronic databases were conducted, including Medline (Ovid), the Excerpta Medica Database, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Central Register of Controlled Trials and WHO regional databases. All studies published after 1 January 1990 were considered. In a few reviews, the GDG and the SREG judged that relevant studies had been published before 1990 and no time limit was used. Studies in at least English, French and Spanish were included; some reviews had no language restrictions. A comprehensive list of search terms was used, including Medical Subject Headings. Criteria for the inclusion and exclusion of literature (for example, study design, sample size and follow-up duration) for the reviews were based on the evidence needed and available to answer the specific research questions. Studies from low- and moderate-income countries (LMICs) and high-income countries were considered. Search strategies and summaries of evidence for each systematic review are reported in Web Appendices 2-27 (see the "Availability of Companion Documents" field). Two independent reviewers screened the titles and abstracts of retrieved references for potentially relevant studies. The full text of all potentially eligible articles was obtained and then reviewed independently by two authors based on inclusion criteria. Duplicate studies were excluded. Refer to Web Appendices 2-27 (see the "Availability of Companion Documents" field) for detailed information on databases searched and search strategies for each review question. Number of Source Documents Please refer to Web Appendices 2-27 (see the "Availability of Companion Documents" field) for the number of source documents included in the systematic review for each of the guideline questions, including the number of documents initially retrieved in the literature search and the number of documents included after removal of duplicates, application of inclusion/exclusion criteria, and quality appraisal. Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Grading of Recommendations Assessment, Development and Evaluation (GRADE) Categories of Quality of Evidence High: The panel is very confident that the true effect lies close to that of the estimate of the effect. Moderate: The panel is moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low: The panel's confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low: The panel has very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of the effect. Methods Used to Analyze the Evidence Meta-Analysis Review of Published Meta-Analyses Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Two independent reviewers extracted data in a predefined evidence table and critically appraised the retrieved studies. Quality was assessed using the Cochrane Collaboration tool to assess the risk of bias of randomized controlled studies (RCTs) and the Newcastle-Ottawa Quality assessment Scale for cohort studies. Any disagreements were resolved through discussion or after consultation with the senior author, when necessary. Meta-analyses of available comparisons were performed using Review Manager version 5.3, as appropriate. Crude estimates were pooled as odds ratios (OR) with 95% confidence intervals (CI) using a random effects model. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the quality of the body of retrieved evidence. Based on the rating of the available evidence, the quality of evidence was graded as "high", "moderate", "low" or "very low" (see the "Rating Scheme for the Strength of the Evidence" field). Refer to Web Appendices 2-27 (see the "Availability of Companion Documents" field) for detailed information on quality of evidence, evidence tables, and results of meta-analyses for each review question. Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations WHO Guideline Development Process The guidelines were developed following the standard recommendations described in the World Health Organization (WHO) Handbook for guideline development (see the "Availability of Companion Documents" field) and according to a scoping proposal approved by the WHO Guidelines Review Committee. The development of the guidelines involved the formation of four main groups to guide the process, and their specific roles are described in the following sections. WHO Guideline Steering Group The WHO Guideline Steering Group was chaired by the director of the Department of Service Delivery and Safety (SDS). Participating members were from the SDS Infection Prevention and Control (IPC) team, the SDS emergency and essential surgical care programme, the Department of Pandemic and Epidemic Diseases, and the IPC team at the WHO Regional Office of the Americas. The Group drafted the initial scoping document for the development of the guidelines. In collaboration with the Guidelines Development Group (GDG), it then identified the primary critical outcomes and priority topics and formulated the related questions in PICO (Patient, Intervention, Comparison, Outcome) format. The Group identified systematic review teams, the guideline methodologist, the members of the GDG and the external reviewers. It supervised also the evidence retrieval and syntheses, organized the