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?
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.
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.
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.
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.
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.
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.
http://anzctr.org.au Identifier: ACTRN12617000475347
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
Dior UP, Kathurusinghe S, Cheng C, et al. Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind Randomized Clinical Trial. JAMA Surg. Published online July 08, 2020. doi:10.1001/jamasurg.2020.1953
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: