Preoperative Application of Chlorhexidine to Reduce Infection with Cesarean Delivery after Labor (PRACTICAL): A Randomized Clinical Trial

Abstract

Objective: To evaluate whether use of both preoperative 2% chlorhexidine gluconate abdominal cloth and 4% chlorhexidine gluconate vaginal scrub are effective in reducing surgical site infections in patients undergoing cesarean delivery after labor. Study Design: This is a single-center, randomized clinical trial in which patients were randomized 1:1 to receive 2% chlorhexidine gluconate cloth applied to the abdomen in addition to the application of 4% chlorhexidine gluconate vaginal scrub versus standard of care. The primary outcome was rate of surgical site infections, including endometritis, by six weeks post-delivery. The secondary outcomes were other wound complications (erythema at the operative site, skin separation, drainage, fever, hematoma, seroma) by six weeks post-delivery, hospital readmission for wound complications, and day of discharge after cesarean delivery. Results: A total of 319 patients between September 2018 and February 2021 met eligibility criteria: 160 were randomized to the chlorhexidine gluconate abdominal cloth and vaginal scrub group and 159 were randomized to the standard of care group. The groups did not have significant differences in maternal demographic characteristics. Of the 302 (95%) individuals included in primary analysis, there was no statistically significant difference in surgical site infection and endometritis rate by six weeks post-delivery (6.6% in chlorhexidine vs 5.3% standard of care, p=0.65). Secondary outcomes were also similar among the two groups. Conclusion: The combination of preoperative 2% chlorhexidine gluconate abdominal cloth and 4% chlorhexidine gluconate vaginal scrub does not appear to reduce the risk of surgical site infection with cesarean delivery after trial of labor when compared to standard of care.