GRAPEVINE, Texas -- Asking patients to clean themselves with chlorhexidine cloths prior to scheduled cesarean delivery did not significantly lower the rate of surgical site infections versus cleaning with placebo cloths in a large randomized trial, a researcher said here.
At 6 weeks postpartum, infections were seen in 2.6% of the chlorhexidine group versus 3.7% in the placebo group (P=0.24), reported Joanne Stone, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues.
At a late-breaking presentation at the Society for Maternal-Fetal Medicine annual meeting, Stone said surgical site infections after cesarean delivery typically occur at rates of 3% to 18%, and these infections have been associated with increased length of hospitalization, increasing pain, depression, and in some cases, mortality.
Stone said prior research has shown chlorhexidine can decrease abundance in skin microflora that may contribute to infections and wipes have been found to decrease infections related to other procedures.
"Most studies don't support a benefit of bathing or showering with chlorhexidine wash, but orthopedic literature [indicates] chlorhexidine cloths can reduce surgical site infections," she noted, adding that there had been no studies on chlorhexidine cloths in patients with scheduled cesarean deliveries.
Participants included women ages 18 and older, at 24 weeks gestation or greater, who were scheduled for a primary or repeat cesarean delivery and had no allergy to chlorhexidine. Both groups received cloths with either 2% chlorhexidine gluconate or placebo, and were instructed via a diagram to use the cloths to clean six body sites both the night before the surgery and after showering the morning of the surgery.
Overall, there were 662 patients in the chlorhexidine group and 647 in the placebo group. Demographic and medical characteristics were similar between groups.
Not only did the chlorhexidine wipes make no difference in the primary outcome, there were also no differences in secondary outcomes including wound complications, readmission for wound infection, or hospital length of stay for the index pregnancy. In post-hoc subgroup analyses examining factors such as obesity, chronic hypertension, diabetes, and asthma, the treatment still appeared to have no benefit. Nor was there any difference between groups in a per-protocol analysis.
Stone told 鶹ý that while the 30% reduction in surgical site infections with chlorhexidine cloths was non-significant, the most notable finding of the study may have been the low rate of surgical site infections that researchers found overall in the study, which was at the bottom end of the range suggested from prior studies.
"It's hard to counsel a patient on rates of surgical site infection [but] now you can tell people you have a low rate of having an infection, and using these cloths doesn't seem to [provide] a benefit," she said.
In fact, Stone said at the presentation that this was the first study to demonstrate the rate of surgical site infection after scheduled cesarean delivery is "very low" -- lower than anticipated -- and that future research should focus on patients with a higher risk of surgical site infection.
At the presentation, a clinician asked Stone if soap and water alone might have an effect, suggesting that patients assigned to the placebo wash may have decreased their risk from that alone.
Stone said it was possible.
"We could not control for showering ... we tell all patients to take a shower the morning of, so it's possible that just taking a shower might help," she said.
Disclosures
The authors disclosed no conflicts of interest.
Primary Source
Society for Maternal-Fetal Medicine
Stone J, et al "Study To Reduce Infection Prior to Elective Cesarean Sections (STRIPES): Double blind RCT using CHG cloths" SMFM 2020; Abstract LB 2.