Study to Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine

Abstract

BACKGROUND Surgical site infections after cesarean delivery are a source of maternal morbidity and usually due to skin microbial flora. Preadmission application of chlorhexidine gluconate via impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora. OBJECTIVE(S) To determine if the application of chlorhexidine gluconate-impregnated cloths the night before and morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks post-operatively compared to placebo cloths. STUDY DESIGN In this single-center, double-blind, placebo-controlled trial, patients were randomized (1:1) to receive either Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo) to apply to 6 skin sites on the body (neck/shoulders/chest, arm pits/arms/hands, abdomen/groin, left leg/foot, right leg/foot, back/buttocks) the night before and after a shower the morning of scheduled cesarean delivery. Routine clinical and operative procedures were followed. The primary outcome was surgical site infections (superficial or deep -incisional and/or organ space-endometritis) by 6 weeks after cesarean delivery. The secondary outcomes were surgical site infections by 2 weeks and other wound-related complications by 2 and 6 weeks after cesarean delivery. RESULTS From April 2015 through August 2019, 1,356 patients were enrolled: 682 were assigned to the chlorhexidine group and 674 to the placebo group. The groups were similar in demographic and medical characteristics. Fourteen patients were lost to follow-up prior to cesarean delivery (10 in chlorhexidine and 4 in placebo) and 33 were lost to follow-up after cesarean delivery (10 in chlorhexidine and 23 in placebo). Among the remaining 1309 (97%), no difference was found in surgical site infections by 6 weeks between the groups (2.6% in chlorhexidine vs. 3.7% in placebo, P=0.24). There were no differences in secondary outcomes at 2 or 6 weeks, and no differences in primary outcome in a per-protocol analysis Conclusion(s): Pre-admission use of chlorhexidine gluconate cloths compared to placebo does not result in a reduction in surgical site infection after scheduled cesarean deliveries. Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.