A course of oral antibiotic therapy after cesarean delivery significantly reduced the rate of surgical site infection (SSI) among obese women, according to the results of a randomized controlled trial.
Carri R. Warshak, MD, from the University of Cincinnati, Ohio, and colleagues reported the results of the single-center, double-blind trial in an article published online September 19 in JAMA.
The researchers enrolled 403 women with a body mass index (BMI) of 30 kg/m2 or higher who were undergoing planned cesarean delivery between October 2010 and December 2015.
All participants received standard preoperative cefazolin prophylaxis (2 g), and were randomly assigned to receive either oral cephalexin (500 mg) and metronidazole (500 mg) or placebo every 8 hours for six doses. Oral medications were started 8 hours after administration of the intravenous cefazolin.
The overall incidence of SSI was 10.9%. In the intervention group, 13 (6.4%) women developed SSIs compared with 31 (15.4%) among those receiving placebo P = .01). This translated to a relative risk of 0.41 (95% CI, 0.22-0.77) for SSI among these treated with prophylactic antibiotics. No allergic reactions or serious adverse events were reported among the women receiving oral antibiotic therapy.
When analyzed according to predelivery membrane status, the researchers found that women with ruptured membranes had a higher risk for SSI compared with those with intact membranes (19.8% vs 6.9%; P < .001).
However, a post hoc analysis showed that among women with ruptured membranes, those assigned to the intervention group experienced lower rates of SSI compared with the placebo group (9.5% vs 30.2%; P = .008).
The study authors also found that although the women receiving postoperative antibiotics experienced lower rates of cellulitis, other secondary outcomes including fever of unknown etiology, wound separation, rates of incisional morbidity, and endometritis were comparable between the groups.
The study authors acknowledge various study limitations, such as limited subgroup numbers, which did not allow for complete analysis of secondary outcomes based on predelivery membrane status.
Promising Results in a Specific Population, but Questions Remain
In an accompanying editorial, David P. Calfee, MD, and Amos Grünebaum, MD, from Weill Cornell Medicine, New York City, note that although these results appear promising, “Additional studies are needed to confirm these findings and to determine if there are specific subpopulations within this group to whom the benefit is limited to avoid unnecessary antibiotic exposure and its associated risks among those unlikely to benefit,” they write.
The editorialists point to several factors that could have led to different results, such as the use of a higher preoperative dose of cefazolin, as is recommended in current clinical practice guidelines, or the use of more current and rigorous SSI prevention measures in this population.
Further, the editorialists note that the risk for infant exposure to antimicrobials, specifically metronidazole, warrants consideration and was not evaluated in this study.
The authors acknowledge that this study included a very specific population of women undergoing cesarean delivery and note that these findings “should not be extrapolated to other populations or other surgical procedures.”
However, Dr Warshak and colleagues go on to conclude that, “[a]mong obese women who undergo cesarean delivery, use of prophylactic oral cephalexin and metronidazole may be warranted for prevention of surgical site infection.”
This study was internally funded by the University of Cincinnati Department of Obstetrics and Gynecology. The authors and one of the editorialists have disclosed no relevant financial relationships. Dr Calfee reports receipt of grants from Merck, Sharpe, and Dohme.
JAMA. 2017;318:1026-1034. Article extract, Editorial extract
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