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Original Investigation
July 8, 2020

Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind Randomized Clinical Trial

Author Affiliations
  • 1Gynaecology Division, The Royal Women’s Hospital, Parkville, Victoria, Australia
  • 2Department of Obstetrics and Gynecology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel
  • 3Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia
  • 4Department of Microbiology and Infectious Disease, The Royal Women’s Hospital, Parkville, Australia
  • 5Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia
JAMA Surg. Published online July 8, 2020. doi:10.1001/jamasurg.2020.1953
Key Points

Question  Does the type of skin preparation solution affect the rate of skin infections and any type of surgical site infections in patients undergoing gynecological laparoscopies?

Findings  In this double-blind randomized clinical trial of 640 patients, the rate of skin infections was 10%, and the overall rate of surgical site infections was 16%. No skin preparation solution provided an advantage compared with the other solutions in reducing infection rates.

Meaning  Rates of surgical site infections in patients undergoing gynecological laparoscopies, one of the most common surgical procedures worldwide, are higher than expected; because the type of skin preparation does not affect rates of surgical site infections, exploring other methods to reduce surgical site infections in patients undergoing gynecological laparoscopies is warranted.

Abstract

Importance  Gynecological laparoscopies are one of the most common surgical procedures worldwide. Limited evidence exists on rates of surgical site infections in patients undergoing gynecological laparoscopies and strategies to prevent these infections.

Objective  To compare rates of port-site infections, organ or space infections, and any type of surgical site infections among patients who underwent gynecological laparoscopies and received 1 of 3 types of skin preparation solutions.

Design, Setting, and Participants  A double-blind randomized clinical trial was conducted between February 28, 2017, and November 26, 2018, at a tertiary university-affiliated referral center. A total of 661 patients 18 years or older who underwent an elective operative laparoscopy for treatment of nonmalignant gynecological disorders were randomly assigned in a 1:1:1 ratio to have their skin cleaned before surgery with alcohol-based chlorhexidine, alcohol-based povidone-iodine, or water-based povidone-iodine. Statistical analysis was performed from February 28, 2017, to November 26, 2018. Analyses were performed on a modified intention-to-treat basis.

Interventions  A total of 221 patients were randomized to have their skin prepared preoperatively with water-based povidone-iodine, 220 were randomized to alcohol-based povidone-iodine, and 220 were randomized to alcohol-based chlorhexidine. The patients were blinded to the solution used to clean their skin. Patients were followed up 1 and 4 weeks after surgery by a physician who was blinded to the skin preparation solution used at surgery. Evidence of infection according to Centers for Disease Control and Prevention criteria were documented.

Main Outcomes and Measures  The primary outcome of this study was port-site infection 30 days after surgery. Secondary outcomes were organ or space infections and any type of surgical site infections; the study also aimed to prospectively describe rates of surgical site infections in gynecological laparoscopies.

Results  Of the 661 patients, 640 (96.8%; mean [SD] age, 36.2 [10.6] years) were examined after surgery by a physician at the study site and were included in the modified intention-to-treat analysis. The overall rate of port-site infection was 10.2% (65 of 640), rate of organ or space infection was 6.6% (42 of 640), and rate of any surgical site infection was 16.3% (104 of 640). The odds ratio for port-site infection for alcohol-based chlorhexidine vs water-based povidone-iodine was 1.13 (95% CI, 0.61-2.08), for alcohol-based chlorhexidine vs alcohol-based povidone-iodine was 1.34 (95% CI, 0.71-2.52), and for water-based povidone-iodine vs alcohol-based povidone-iodine was 1.19 (95% 0.62-2.27).

Conclusions and Relevance  Surgical site infections were more common than expected among patients who underwent gynecological laparoscopies. No skin preparation solution provided an advantage compared with the other solutions in reducing infection rates.

Trial Registration  http://anzctr.org.au Identifier: ACTRN12617000475347

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