Nisha A Lakhi1, Gabrielle Tricorico2, Yevgeniya Osipova2, Michael L Moretti2. 1. Department of Obstetrics and Gynecology, Richmond University Medical Center, Staten Island, NY; Department of Obstetrics and Gynecology, New York Medical College, Valhalla, NY. Electronic address: nlakhi@RUMCSI.org. 2. Department of Obstetrics and Gynecology, Richmond University Medical Center, Staten Island, NY.
Abstract
BACKGROUND: Several randomized controlled trials have demonstrated that preoperative abdominal skin preparation with chlorhexidine gluconate is superior to povidone-iodine for the prevention of surgical site infections. Despite these results, povidone-iodine is still the most commonly used agent for vaginal preparation, even though it may not be ideal. OBJECTIVES: The objectives of the study were as follows: (1) to determine whether vaginal cleansing with a 4% chlorhexidine gluconate solution results in fewer wound infections as compared with povidone-iodine when used for vaginal antisepsis prior to cesarean delivery and (2) to compare rates of patient reported side-effects associated with vaginal application of 4% chlorhexidine gluconate solution and 10% povidone-iodine. STUDY DESIGN: This is a block randomized, comparator-controlled, open-label trial. Women undergoing nonemergent cesarean delivery were randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% povidone-iodine solution prior to skin incision. The primary outcome was wound site infection occurring within 14 days of cesarean delivery including superficial or deep surgical site infection. Secondary outcomes included rates of endometritis, postoperative fever, and side effects (vaginal dryness, irritation, and desquamitization) occurring within 14 days of cesarean delivery. Risks were reported as odds ratios with 95% confidence intervals, with P < .05 considered as significant. RESULTS: From Dec. 1, 2016, through Feb. 28, 2018, a total of 1,114 patients met the inclusion criteria: 524 were randomized to the chlorhexidine gluconate arm and 590 to the povidone-iodine arm. Both arms were similar with regard to age, parity, body mass index, gestational age at delivery, indication for cesarean delivery, and incidence of membrane rupture. The rate of wound infection was significantly lower in the chlorhexidine arm as compared with povidone-iodine (0.6% vs 2.0%; P = .039, odds ratio, 0.28, 95% confidence interval, 0.08-0.98). Rates of endometritis (0.4% vs 0.5%, P = 1.000) and postoperative fever (2.5% and 2.7%, P = 0.892) were similar for the chlorhexidine and povidone-iodine groups, respectively. No adverse effects on the vaginal mucosa were noted for either solution. CONCLUSION:Vaginal cleansing with a 4% chlorhexidine solution prior to cesarean delivery resulted in fewer overall wound infections when compared with povidone-iodine solution with no patient-reported adverse reactions.
RCT Entities:
BACKGROUND: Several randomized controlled trials have demonstrated that preoperative abdominal skin preparation with chlorhexidine gluconate is superior to povidone-iodine for the prevention of surgical site infections. Despite these results, povidone-iodine is still the most commonly used agent for vaginal preparation, even though it may not be ideal. OBJECTIVES: The objectives of the study were as follows: (1) to determine whether vaginal cleansing with a 4% chlorhexidine gluconate solution results in fewer wound infections as compared with povidone-iodine when used for vaginal antisepsis prior to cesarean delivery and (2) to compare rates of patient reported side-effects associated with vaginal application of 4% chlorhexidine gluconate solution and 10% povidone-iodine. STUDY DESIGN: This is a block randomized, comparator-controlled, open-label trial. Women undergoing nonemergent cesarean delivery were randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% povidone-iodine solution prior to skin incision. The primary outcome was wound site infection occurring within 14 days of cesarean delivery including superficial or deep surgical site infection. Secondary outcomes included rates of endometritis, postoperative fever, and side effects (vaginal dryness, irritation, and desquamitization) occurring within 14 days of cesarean delivery. Risks were reported as odds ratios with 95% confidence intervals, with P < .05 considered as significant. RESULTS: From Dec. 1, 2016, through Feb. 28, 2018, a total of 1,114 patients met the inclusion criteria: 524 were randomized to the chlorhexidine gluconate arm and 590 to the povidone-iodine arm. Both arms were similar with regard to age, parity, body mass index, gestational age at delivery, indication for cesarean delivery, and incidence of membrane rupture. The rate of wound infection was significantly lower in the chlorhexidine arm as compared with povidone-iodine (0.6% vs 2.0%; P = .039, odds ratio, 0.28, 95% confidence interval, 0.08-0.98). Rates of endometritis (0.4% vs 0.5%, P = 1.000) and postoperative fever (2.5% and 2.7%, P = 0.892) were similar for the chlorhexidine and povidone-iodine groups, respectively. No adverse effects on the vaginal mucosa were noted for either solution. CONCLUSION: Vaginal cleansing with a 4% chlorhexidine solution prior to cesarean delivery resulted in fewer overall wound infections when compared with povidone-iodine solution with no patient-reported adverse reactions.