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Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for Preoperative Skin Antisepsis


Widmer, Andreas F; Atkinson, Andrew; Kuster, Stefan P; Wolfensberger, Aline; Klimke, Steffi; Sommerstein, Rami; Eckstein, Friedrich S; Schoenhoff, Florian; Beldi, Guido; Gutschow, Christian A; Marschall, Jonas; Schweiger, Alexander; Jent, Philipp (2024). Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for Preoperative Skin Antisepsis. JAMA : the Journal of the American Medical Association:Epub ahead of print.

Abstract

Importance: Preoperative skin antisepsis is an established procedure to prevent surgical site infections (SSIs). The choice of antiseptic agent, povidone iodine or chlorhexidine gluconate, remains debated.
Objective: To determine whether povidone iodine in alcohol is noninferior to chlorhexidine gluconate in alcohol to prevent SSIs after cardiac or abdominal surgery.
Design, Setting, and Participants: Multicenter, cluster-randomized, investigator-masked, crossover, noninferiority trial; 4403 patients undergoing cardiac or abdominal surgery in 3 tertiary care hospitals in Switzerland between September 2018 and March 2020 were assessed and 3360 patients were enrolled (cardiac, n = 2187 [65%]; abdominal, n = 1173 [35%]). The last follow-up was on July 1, 2020.InterventionsOver 18 consecutive months, study sites were randomly assigned each month to either use povidone iodine or chlorhexidine gluconate, each formulated in alcohol. Disinfectants and skin application processes were standardized and followed published protocols.
Main Outcomes and Measures: Primary outcome was SSI within 30 days after abdominal surgery and within 1 year after cardiac surgery, using definitions from the US Centers for Disease Control and Prevention’s National Healthcare Safety Network. A noninferiority margin of 2.5% was used. Secondary outcomes included SSIs stratified by depth of infection and type of surgery.
Results: A total of 1598 patients (26 cluster periods) were randomly assigned to receive povidone iodine vs 1762 patients (26 cluster periods) to chlorhexidine gluconate. Mean (SD) age of patients was 65.0 years (39.0-79.0) in the povidone iodine group and 65.0 years (41.0-78.0) in the chlorhexidine gluconate group. Patients were 32.7% and 33.9% female in the povidone iodine and chlorhexidine gluconate groups, respectively. SSIs were identified in 80 patients (5.1%) in the povidone iodine group vs 97 (5.5%) in the chlorhexidine gluconate group, a difference of 0.4% (95% CI, −1.1% to 2.0%) with the lower limit of the CI not exceeding the predefined noninferiority margin of −2.5%; results were similar when corrected for clustering. The unadjusted relative risk for povidone iodine vs chlorhexidine gluconate was 0.92 (95% CI, 0.69-1.23). Nonsignificant differences were observed following stratification by type of surgical procedure. In cardiac surgery, SSIs were present in 4.2% of patients with povidone iodine vs 3.3% with chlorhexidine gluconate (relative risk, 1.26 [95% CI, 0.82-1.94]); in abdominal surgery, SSIs were present in 6.8% with povidone iodine vs 9.9% with chlorhexidine gluconate (relative risk, 0.69 [95% CI, 0.46-1.02]).Conclusions and RelevancePovidone iodine in alcohol as preoperative skin antisepsis was noninferior to chlorhexidine gluconate in alcohol in preventing SSIs after cardiac or abdominal surgery.Trial RegistrationClinicalTrials.gov Identifier: NCT03685604

Abstract

Importance: Preoperative skin antisepsis is an established procedure to prevent surgical site infections (SSIs). The choice of antiseptic agent, povidone iodine or chlorhexidine gluconate, remains debated.
Objective: To determine whether povidone iodine in alcohol is noninferior to chlorhexidine gluconate in alcohol to prevent SSIs after cardiac or abdominal surgery.
Design, Setting, and Participants: Multicenter, cluster-randomized, investigator-masked, crossover, noninferiority trial; 4403 patients undergoing cardiac or abdominal surgery in 3 tertiary care hospitals in Switzerland between September 2018 and March 2020 were assessed and 3360 patients were enrolled (cardiac, n = 2187 [65%]; abdominal, n = 1173 [35%]). The last follow-up was on July 1, 2020.InterventionsOver 18 consecutive months, study sites were randomly assigned each month to either use povidone iodine or chlorhexidine gluconate, each formulated in alcohol. Disinfectants and skin application processes were standardized and followed published protocols.
Main Outcomes and Measures: Primary outcome was SSI within 30 days after abdominal surgery and within 1 year after cardiac surgery, using definitions from the US Centers for Disease Control and Prevention’s National Healthcare Safety Network. A noninferiority margin of 2.5% was used. Secondary outcomes included SSIs stratified by depth of infection and type of surgery.
Results: A total of 1598 patients (26 cluster periods) were randomly assigned to receive povidone iodine vs 1762 patients (26 cluster periods) to chlorhexidine gluconate. Mean (SD) age of patients was 65.0 years (39.0-79.0) in the povidone iodine group and 65.0 years (41.0-78.0) in the chlorhexidine gluconate group. Patients were 32.7% and 33.9% female in the povidone iodine and chlorhexidine gluconate groups, respectively. SSIs were identified in 80 patients (5.1%) in the povidone iodine group vs 97 (5.5%) in the chlorhexidine gluconate group, a difference of 0.4% (95% CI, −1.1% to 2.0%) with the lower limit of the CI not exceeding the predefined noninferiority margin of −2.5%; results were similar when corrected for clustering. The unadjusted relative risk for povidone iodine vs chlorhexidine gluconate was 0.92 (95% CI, 0.69-1.23). Nonsignificant differences were observed following stratification by type of surgical procedure. In cardiac surgery, SSIs were present in 4.2% of patients with povidone iodine vs 3.3% with chlorhexidine gluconate (relative risk, 1.26 [95% CI, 0.82-1.94]); in abdominal surgery, SSIs were present in 6.8% with povidone iodine vs 9.9% with chlorhexidine gluconate (relative risk, 0.69 [95% CI, 0.46-1.02]).Conclusions and RelevancePovidone iodine in alcohol as preoperative skin antisepsis was noninferior to chlorhexidine gluconate in alcohol in preventing SSIs after cardiac or abdominal surgery.Trial RegistrationClinicalTrials.gov Identifier: NCT03685604

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Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Infectious Diseases
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > General Medicine
Language:English
Date:17 June 2024
Deposited On:10 Jul 2024 13:10
Last Modified:11 Jul 2024 20:00
Publisher:American Medical Association (AMA)
ISSN:0098-7484
OA Status:Closed
Publisher DOI:https://doi.org/10.1001/jama.2024.8531
PubMed ID:38884982
Project Information:
  • : FunderSNSF
  • : Grant ID173534
  • : Project TitleChlorhexidine vs PVP iodine in alcohol for disinfection of the surgical site: a cluster-randomized multicenter trial