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

BACKGROUND

Surgical site infections after cesarean delivery are a cause of maternal morbidity and are typically caused by skin microbial flora. Preadmission application of chlorhexidine gluconate using impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora.

OBJECTIVE

To determine whether the application of chlorhexidine gluconate cloths the night before and the morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks postoperatively compared with placebo.

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 and chest, armpits, arm and hands, abdomen and groin, left leg and foot, right leg and foot, back and 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 with or without 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 to August 2019, 1356 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. A total of 14 patients were lost to follow-up before 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 2 groups (2.6% in chlorhexidine vs 3.7% in placebo; P=.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

Preadmission use of chlorhexidine gluconate cloths compared with placebo does not reduce the risk of surgical site infection after scheduled cesarean deliveries. Following the standard of care guidelines results in a low risk of surgical site infections in this group of patients.