On January 31, 2020, the US Food and Drug Administration (FDA) issued a voluntary recall of bacitracin for injection due to efficacy and safety concerns, including nephrotoxicity, anaphylactic reactions, and the need for repeated intramuscular injections.¹ The drug is active in vitro against most gram-positive organisms, including Staphylococcus aureus. Its only approved indication is for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, but off-label use of bacitracin for intraoperative irrigation of surgical wounds is widespread in hospitals across the United States.² One survey showed that>50% of general and orthopedic surgeons, 30%–39% of neurosurgical and spinal surgeons, 26% of cardiothoracic surgeons, and 22%–23% of obstetrics-gynecology and plastic surgeons use antibiotic irrigation fluids, often containing bacitracin.^{Reference Edmiston, Spencer and Leaper3}

High-quality evidence to support the use of intraoperative antimicrobial irrigations to prevent surgical site infections (SSIs) is lacking.^{Reference Edmiston, Leaper and Spencer4,Reference de Jonge, Boldingh and Solomkin5} Multiple guidelines on SSI prevention as well as the International Consensus Meeting on Orthopedic Infections statement either do not recommend the use of antibiotic irrigations or, due to insufficient evidence, make no recommendation (Table 1).^{Reference Blom, Cho and Fleischman6} Published literature on antibiotic irrigations for the prevention of SSIs mostly consists of retrospective, observational, single-center studies across a variety of surgery types including orthopedic, neurosurgical, cardiac, abdominal, vascular, and breast reconstruction procedures.^{Reference Edmiston, Leaper and Spencer4,Reference Blom, Cho and Fleischman6,Reference Norman, Atkinson and Smith11}

Table 1. Summary Guideline Recommendations on Topical Antimicrobial or Antiseptic Therapy to Reduce Surgical Site Infections

Abbreviations: ASHP: American Society of Health-System Pharmacists; IDSA: Infectious Diseases Society of America; SIS: Surgical Infection Society; SHEA: Society for Healthcare Epidemiology of America. ACS: American College of Surgeons; CDC: Centers for Disease Control; WHO: World Health Organization

Reviews and meta-analyses conducted in the last 60 years have repeatedly concluded that available studies have been flawed and of low quality, and that they are insufficient to support intraoperative topical antibiotics for SSI prevention.^{Reference Edmiston, Leaper and Spencer4} One recent meta-analysis of 21 randomized-controlled trials (RCTs) found no benefit of antibiotic irrigations compared to saline or no irrigation (OR, 1.16; 95% CI, 0.64–2.12; P = .63), but it found a decrease in SSIs with the use of intraoperative aqueous povidone-iodine solution compared to saline irrigation (OR, 0.31; 95% CI, 0.13–0.73; P = .007).^{Reference de Jonge, Boldingh and Solomkin5} A Cochrane analysis found that there may be a lower incidence of SSI in participants treated with antibacterial irrigation solutions compared with nonantibacterial (ie, saline) irrigants in patients undergoing abdominal, spine, orthopedic, gynecologic, vascular, thoracic, and general surgeries.^{Reference Norman, Atkinson and Smith11} This tentative conclusion was, however, based only on low-level evidence, which was downgraded because of a risk of publication bias as well as overall bias involving a variety of domains. Furthermore, the “antibacterial” group included individuals that received either antibiotics or antiseptics, making results difficult to interpret.

Irrigation with a triple antibiotic solution (commonly cefazolin, bacitracin, and gentamicin) is currently frequently used with the hope of reducing SSI and capsular contracture rates in breast implant surgery, despite conflicting evidence for efficacy.² Drinane et al conducted a meta-analysis of 8 studies (2 case series and 6 retrospective studies) with 10,923 total patients and failed to detect a decreased incidence of capsular contracture in association with antimicrobial irrigation of implant pockets.² No trials have directly compared antibiotic to antiseptic irrigations for the prevention of SSIs.^{Reference Edmiston, Leaper and Spencer4,Reference Norman, Atkinson and Smith11}

The American Heart Association Scientific Statement on the management of cardiovascular implantable electronic device infections makes no recommendations on the use of antimicrobial irrigation of the pocket.²