• N. Engl. J. Med. · Feb 2016

    Randomized Controlled Trial Comparative Study

    A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

    • Methodius G Tuuli, Jingxia Liu, Molly J Stout, Shannon Martin, Alison G Cahill, Anthony O Odibo, Graham A Colditz, and George A Macones.
    • From the Department of Obstetrics and Gynecology (M.G.T., M.J.S., S.M., A.G.C., G.A.M.) and the Division of Public Health Sciences (J.L., G.A.C.), Washington University School of Medicine in St. Louis, St. Louis; and the Department of Obstetrics and Gynecology, University of South Florida, Tampa (A.O.O.).
    • N. Engl. J. Med. 2016 Feb 18; 374 (7): 647655647-55.

    BackgroundPreoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States.MethodsIn this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine-alcohol or iodine-alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention.ResultsFrom September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine-alcohol and 575 to iodine-alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine-alcohol group and in 42 (7.3%) in the iodine-alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P=0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine-alcohol group and 4.9% in the iodine-alcohol group (P=0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P=0.07). The frequency of adverse skin reactions was similar in the two groups.ConclusionsThe use of chlorhexidine-alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine-alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.).

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