Biomaterial Database

Surgical Hand Antisepsis and Surgical Site Infections. 2016

Brad S Oriel, and Kamal M F Itani

1 Department of Surgery, Veterans Affairs Boston Healthcare System , West Roxbury, Massachusetts.

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 105-107 CFU/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.

UI	MeSH Term	Description	Entries
D011300	Preoperative Care	Care given during the period prior to undergoing surgery when psychological and physical preparations are made according to the special needs of the individual patient. This period spans the time between admission to the hospital to the time the surgery begins. (From Dictionary of Health Services Management, 2d ed)	Care, Preoperative,Preoperative Procedure,Preoperative Procedures,Procedure, Preoperative,Procedures, Preoperative
D006235	Hand Disinfection	The act of cleansing the hands with water or other liquid, with or without the inclusion of soap or other detergent, for the purpose of destroying infectious microorganisms.	Disinfection, Hand,Handwashing,Hand Sanitization,Hand Washing,Scrubbing, Surgical,Surgical Scrubbing,Hand Washings,Sanitization, Hand,Washing, Hand,Washings, Hand
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000891	Anti-Infective Agents, Local	Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects.	Anti-Infective Agents, Topical,Antiseptic,Antiseptics,Microbicides, Local,Microbicides, Topical,Antiinfective Agents, Local,Antiinfective Agents, Topical,Local Anti-Infective Agents,Local Antiinfective Agents,Topical Anti-Infective Agents,Topical Antiinfective Agents,Agents, Local Anti-Infective,Agents, Local Antiinfective,Agents, Topical Anti-Infective,Agents, Topical Antiinfective,Anti Infective Agents, Local,Anti Infective Agents, Topical,Local Anti Infective Agents,Local Microbicides,Topical Anti Infective Agents,Topical Microbicides
D000985	Antisepsis	The destruction of germs causing disease.
D013530	Surgical Wound Infection	Infection occurring at the site of a surgical incision.	Postoperative Wound Infection,Infection, Postoperative Wound,Infection, Surgical Wound,Surgical Site Infection,Wound Infection, Postoperative,Wound Infection, Surgical,Infection, Surgical Site,Infections, Postoperative Wound,Infections, Surgical Site,Infections, Surgical Wound,Postoperative Wound Infections,Surgical Site Infections,Surgical Wound Infections,Wound Infections, Postoperative,Wound Infections, Surgical
D017410	Practice Guidelines as Topic	Works about directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.	Clinical Guidelines as Topic,Best Practices,Best Practice
D049672	History, 19th Century	Time period from 1801 through 1900 of the common era.	19th Century History,19th Cent. History (Medicine),19th Cent. History of Medicine,19th Cent. Medicine,Historical Events, 19th Century,History of Medicine, 19th Cent.,History, Nineteenth Century,Medical History, 19th Cent.,Medicine, 19th Cent.,19th Cent. Histories (Medicine),19th Century Histories,Cent. Histories, 19th (Medicine),Cent. History, 19th (Medicine),Century Histories, 19th,Century Histories, Nineteenth,Century History, 19th,Century History, Nineteenth,Histories, 19th Cent. (Medicine),Histories, 19th Century,Histories, Nineteenth Century,History, 19th Cent. (Medicine),Nineteenth Century Histories,Nineteenth Century History
D049673	History, 20th Century	Time period from 1901 through 2000 of the common era.	20th Century History,20th Cent. History (Medicine),20th Cent. History of Medicine,20th Cent. Medicine,Historical Events, 20th Century,History of Medicine, 20th Cent.,History, Twentieth Century,Medical History, 20th Cent.,Medicine, 20th Cent.,20th Cent. Histories (Medicine),20th Century Histories,Cent. Histories, 20th (Medicine),Cent. History, 20th (Medicine),Century Histories, 20th,Century Histories, Twentieth,Century History, 20th,Century History, Twentieth,Histories, 20th Cent. (Medicine),Histories, 20th Century,Histories, Twentieth Century,History, 20th Cent. (Medicine),Twentieth Century Histories,Twentieth Century History
D049674	History, 21st Century	Time period from 2001 through 2100 of the common era.	21st Century History,21st Cent. History (Medicine),21st Cent. History of Medicine,21st Cent. Medicine,Historical Events, 21st Century,History of Medicine, 21st Cent.,History, Twenty-first Century,Medical History, 21st Cent.,Medicine, 21st Cent.,21st Cent. Histories (Medicine),21st Cent. Medicines,21st Century Histories,Cent. Histories, 21st (Medicine),Cent. History, 21st (Medicine),Cent. Medicine, 21st,Cent. Medicines, 21st,Century Histories, 21st,Century Histories, Twenty-first,Century History, 21st,Century History, Twenty-first,Histories, 21st Cent. (Medicine),Histories, 21st Century,Histories, Twenty-first Century,History, 21st Cent. (Medicine),History, Twenty first Century,Medicines, 21st Cent.,Twenty-first Century Histories,Twenty-first Century History