Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE

To compare chlorhexidine with alcohol, povidone-iodine with alcohol, and both applied sequentially to estimate their relative effectiveness in prevention of surgical site infections after cesarean delivery.

METHODS

Women undergoing nonemergent cesarean birth at greater than 37 0/7 weeks of gestation were randomly allocated to one of three antiseptic skin preparations: povidone-iodine with alcohol, chlorhexidine with alcohol, or the sequential combination of both solutions. The primary outcome was surgical site infection reported within the first 30 days postpartum. Based on a surgical site infection rate of 12%, an anticipated 50% reduction for the combination group relative to either single skin preparation group, with a power of 0.90 and an α of 0.05, 430 women per group were needed to detect a difference.

RESULTS

From January 2013 to July 2014, 1,404 women were randomly assigned to one of three groups: povidone-iodine with alcohol (n=463), chlorhexidine with alcohol (n=474), or both (n=467). The groups were similar with respect to demographics, medical disorders, indication for cesarean delivery, operative time, and blood loss. The overall rate of surgical site infection-4.3%-was lower than anticipated. The skin preparation groups had similar surgical site infection rates: povidone-iodine 4.6%, chlorhexidine with alcohol 4.5%, and sequential 3.9% (P=.85).

CONCLUSION

The skin preparation techniques resulted in similar rates of surgical site infections. Our study provides no support for any particular method of skin preparation before cesarean delivery.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01870583.

LEVEL OF EVIDENCE: I.