title: Surgical Hand Antisepsis and Surgical Site Infections.
abstract: BACKGROUND
  Surgical site infections (SSI) remain a significant problem to both the patients and the healthcare system. Value care and standardized quality measures continue to promote improvement in surgical asepsis, but certain debates remain unresolved in the field of surgical hand antisepsis.
  
  
  METHODS
  Review of relevant accounts and literature.
  
  
  RESULTS
  Controversy has existed regarding the U.S. Food and Drug Administration (FDA)'s 1994 Tentative Final Monograph (TFM), which defined how surgical hand antisepsis products are assessed. Issues involving neutralizers and demonstration of a cumulative effect were addressed in the FDA's Proposed Rule in 2015. Few studies have used SSI as a primary outcome and instead have used a surrogate marker (colony-forming units [CFU]). Quantitative microbiology studies suggest a minimum bacterial inoculum of 105-107CFU/mL is necessary to cause a clinical infection. Outcomes of antisepsis likely are driven by both active ingredient(s) and overall product formulation. Povidone-iodine aqueous scrubs are inferior to chlorhexidine gluconate (CHG) 4% aqueous scrubs and alcohol-based rubs (ABR). The SSI and CFU outcomes studies support the equivalence or superiority of ABR over CHG.
  
  
  CONCLUSIONS
  Both ABRs and CHG 4% are preferred to povidone-iodine for surgical hand antisepsis. Well-powered randomized controlled trials measuring SSI as a primary outcome, as well as those designed according to either TFM or European methodology, with appropriate controls and neutralizers, are warranted. These trials should incorporate different ABR formulations and CHG 4%, as well as skin tolerance assessments and a cost analysis.
authors: 1 Department of Surgery, Veterans Affairs Boston Healthcare System , West Roxbury, Massachusetts.|2 Department of Surgery, Tufts University School of Medicine , Boston, Massachusetts.
authors: Brad S
authors: BS
authors: Oriel
authors: 1 Department of Surgery, Veterans Affairs Boston Healthcare System , West Roxbury, Massachusetts.|2 Department of Surgery, Tufts University School of Medicine , Boston, Massachusetts.|3 Department of Surgery, Boston University School of Medicine , Boston, Massachusetts.|4 Harvard Medical School , Boston, Massachusetts.
authors: Kamal M F
authors: KM
authors: Itani
mesh_terms: D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D000985:Antisepsis / Q000266:history / Q000379:methods; D006235:Hand Disinfection; D049672:History, 19th Century; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D017410:Practice Guidelines as Topic; D011300:Preoperative Care; D013530:Surgical Wound Infection
chemical_list: D000891:Anti-Infective Agents, Local