Abstract
To compare rates of postoperative wound complications among women with Class III obesity (BMI ≥ 40) undergoing cesarean delivery (CD) with skin closure either by subcuticular sutures vs surgical staples. Patients were randomly assigned to skin closure by staples or subcuticular suture at the time of CD. Randomization was stratified for scheduled or unscheduled/labored CD and for the two study sites. The primary outcome was the rate of any documented wound complication during the first six weeks postpartum. Covariates considered were gestational age at delivery, number of prior CDs, diabetes diagnosis, labor, preoperative antibiotic use, preoperative vaginal prep, and tobacco use. To further evaluate the surgical outcome in this population, we also considered location of incision and incision to delivery interval. Sample size was calculated based on published literature and estimating a rate of wound complications at 6 weeks of follow-up at 20% with staples and 10% with sutures. For a power of 0.80 with a two-tailed of 0.05, an N of 199 per group was required. Nearing the planned interim analysis, enrollment in the study was concluded administratively due to extended duration. From September 2015 through May 2019, 232 women were randomized at two University hospitals, 120 to staples and 111 to sutures. Fewer wound complications were noted in the surgical staples group when compared to the subcuticular suture group (24.4 vs. 34.1%), although this difference was not found to be statistically significant (RR 0.72, 95% CI 0.43-1.18, p=0.185). In multiple logistic regression, the two significant independent predictors of the outcome were BMI (OR 2.35, 95% CI 1.16-4.76) and unscheduled CD (OR 1.11, 95% CI 1.06-1.18). Among obese women with BMI ≥ 40 undergoing CD, wound complication rates in the first 6 weeks postpartum are not significantly different when comparing skin closure using either surgical staples or subcuticular suture. The results of our study demonstrate that either technique is acceptable, allowing physician and patient preferences to be considered.
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