SURGICAL INFECTIONS Volume 14, Number 1, 2013 Surgical Infection Mary Ann Liebert, Inc. DOI: 10.1089/sur.2013.9999 Society Guidelines Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery Dale W. Bratzler,1 E. Patchen Dellinger,2 Keith M. Olsen,3 Trish M. Perl,4 Paul G. Auwaerter,5 Maureen K. Bolon,6 Douglas N. Fish,7 Lena M. Napolitano,8 Robert G. Sawyer,9 Douglas Slain,10 James P. Steinberg,11 and Robert A. Weinstein12 hese guidelines were developed jointly by the Ameri- the project. Panel members and contractors were required to Tcan Society of Health-System Pharmacists (ASHP), the disclose any possible conflicts of interest before their ap- Infectious Diseases Society of America (IDSA), the Surgical pointment and throughout the guideline development pro- Infection Society (SIS), and the Society for Healthcare Epide- cess. Drafted documents for each surgical procedural section miology of America (SHEA). This work represents an update were reviewed by the expert panel and, once revised, were to the previously published ASHP Therapeutic Guidelines on available for public comment on the ASHP website. After Antimicrobial Prophylaxis in Surgery [1], as well as guide- additional revisions were made to address reviewer com- lines from IDSA and SIS [2,3]. The guidelines are intended to ments, the final document was approved by the expert panel provide practitioners with a standardized approach to the and the boards of directors of the above-named organizations. rational, safe, and effective use of antimicrobial agents for the prevention of surgical site infections (SSIs) based on currently Strength of evidence and grading of recommendations available clinical evidence and emerging issues. The primary literature from the previous ASHP Therapeutic Prophylaxis refers to the prevention of an infection and can Guidelines on Antimicrobial Prophylaxis in Surgery [1] was be characterized as primary prophylaxis, secondary prophy- reviewed together with the primary literature published be- laxis, or eradication. Primary prophylaxis refers to the pre- tween the date of the previous guidelines, 1999, and June 2010, vention of an initial infection. Secondary prophylaxis refers to identified by searches of MEDLINE, EMBASE, and the Co- the prevention of recurrence or reactivation of a preexisting chrane Database of Systematic Reviews. Particular attention infection. Eradication refers to the elimination of a colonized was paid to study design, with greatest credence given to organism to prevent the development of an infection. These randomized, controlled, double-blind studies. There is a lim- guidelines focus on primary perioperative prophylaxis. ited number of adequately powered randomized controlled trials evaluating the efficacy of antimicrobial prophylaxis in Guidelines development and use surgical procedures. Guidelines development included con- Members of ASHP, IDSA, SIS, and SHEA were appointed sideration of the following characteristics: validity, reliability, to serve on an expert panel established to ensure the validity, clinical applicability, flexibility, clarity, and a multidisciplinary reliability, and utility of the revised guidelines. The work of nature as consistent with ASHP’s philosophy on therapeutic the panel was facilitated by faculty of the University of guidelines [4]. The limitations of the evidence base are noted Pittsburgh School of Pharmacy and University of Pittsburgh within each individual procedure section of the guidelines. Medical Center Drug Use and Disease State Management Published guidelines with recommendations by experts in a Program who served as contract researchers and writers for procedure area (e.g., American College of Obstetricians and 1College of Public Health, and Professor, College of Medicine, Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma. 2Department of Surgery, and Chief, Division of General Surgery, University of Washington, Seattle, Washington. 3Nebraska Medical Center, Omaha, Nebraska. 4Pathology, and Epidemiology, Johns Hopkins University, and Senior Epidemiologist, The Johns Hopkins Health System, Baltimore, Maryland. 5Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, Maryland. 6Division of Infectious Diseases, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 7Department of Clinical Pharmacy, University of Colorado, Anschultz Medical Campus, and Clinical Specialist, Critical Care/Infectious Diseases, Department of Pharmacy Services, University of Colorado Hospital, Aurora, Colorado. 8Acute Care Surgery, Trauma, Burn, Critical Care, Emergency Surgery, and Associate Chair of Surgery, Critical Care, Department of Surgery, and Director, Surgical Critical Care, University of Michigan Health System, Ann Arbor, Michigan. 9Public Health Sciences, and Chief, Division of Acute Care Surgery and Outcomes Research, University of Virginia Health System, Charlottesville, Virginia. 10Pharmacy and Medicine, West Virginia University, Morgantown, West Virginia. 11Division of Infectious Diseases, Emory University, Atlanta, Georgia. 12Rush Medical College, Chicago, and Chairman, Department of Medicine, Cook County Health and Hospital System, Chicago, Illinois. Copyright ª 2013, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/13/0201-0195$06.00. 73 74 SURGICAL PROPHYLAXIS GUIDELINES Gynecologists [ACOG]) and noted general guidelines (e.g., U.S. Preoperative-dose timing. The optimal time for admin- Centers for Disease Control and Prevention [CDC], Scottish istration of preoperative doses is within 60 min before surgi- Intercollegiate Guidelines Network, Medical Letter,SIS,SHEA/ cal incision. This is a more-specific time frame than the IDSA) were also considered [2,3,5–11]. previously recommended time, which was ‘‘at induction of Recommendations for the use of antimicrobial prophylaxis anesthesia.’’ Some agents, such as fluoroquinolones and are graded according to the strength of evidence available. The vancomycin, require administration over one to two hours; strength of evidence represents only support for or against therefore, the administration of these agents should begin prophylaxis and does not apply to the antimicrobial agent, dose, within 120 min before surgical incision. or dosage regimen. Studies supporting the recommendations for the use of antimicrobial therapy were classified as follows: Selection and dosing. Information is included regarding the approach to weight-based dosing in obese patients and the Level I (evidence from large, well-conducted, random- need for repeat doses during prolonged procedures [13–18]. ized, controlled clinical trials or a meta-analysis), Obesity has been linked to an increased risk for SSI. The Level II (evidence from small, well-conducted, ran- pharmacokinetics of drugs may be altered in obese patients, so domized, controlled clinical trials), dosage adjustments based on body weight may be warranted Level III (evidence from well-conducted cohort studies), in these patients. For all patients, intraoperative redosing is Level IV (evidence from well-conducted case–control needed to ensure adequate serum and tissue concentrations of studies), the antimicrobial if the duration of the procedure exceeds two Level V (evidence from uncontrolled studies that were half-lives of the drug or there is excessive blood loss during the not well conducted), procedure (Table 1). Recommendations for selection of anti- Level VI (conflicting evidence that tends to favor the microbial agents for specific surgical procedures and alterna- recommendation), or tive agents (e.g., for patients with allergies to b-lactam Level VII (expert opinion or data extrapolated from antimicrobials) are provided in Table 2. evidence for general principles and other procedures). Duration of prophylaxis. This system has been used by the Agency for Healthcare New recommendations for a Research and Quality, and ASHP, IDSA, SIS, and SHEA shortened postoperative course of antimicrobials involving a support it as an acceptable method for organizing strength of single dose or continuation for less than 24 hours are pro- evidence for a variety of therapeutic or diagnostic recom- vided. Further clarity on the lack of need for postoperative mendations [4]. Each recommendation was categorized ac- antimicrobial prophylaxis based on the presence of indwell- cording to the strength of evidence that supports the use or ing drains and intravascular catheters is included. nonuse of antimicrobial prophylaxis as category A (levels Common principles. A section addressing concepts that I–III), category B (levels IV–VI), or category C (level VII). apply to all types of surgical procedures has been added. When higher-level data are not available, a category C Expanded and new recommendations are provided for plas- recommendation represents a consensus of expert panel tic, urology, cardiac, and thoracic procedures, as well as members based on their clinical experience, extrapolation clarity on prophylaxis when implantable devices are inserted. from other procedures with similar microbial or other clinical The latest information on the use of mupirocin and on the role features, and available published literature. In these cases, the of vancomycin in surgical prophylaxis is summarized in these expert panel also extrapolated general principles and evi- updated guidelines. dence from other procedures. Some recommendations in- clude alternative approaches in situations in which panel Application of