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

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.