A Randomized Controlled Trial of Early Versus Delayed Skin Staple Removal Following Caesarean Section in the Obese Patient

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Abstract

Objective: To compare wound complications after Caesarean section in the obese patient, following early versus delayed skin staple removal. Methods: We conducted a single-centre, non-inferiority, randomized controlled trial Following Caesarean section, obese women (BMI ≥ 30 kg/m2) with subcutaneous wound depth ≥ 2.0 cm and skin staple closure of a transverse incision were randomized to staple removal on postoperative day 3 (early) or between postoperative day 7 and postoperative day 10 (delayed) The primary outcome was superficial wound dehiscence; a rate of 8% or higher in the early group was defined as inferior. Secondary outcomes were seroma/hematoma, surgical site infection, and visual analogue pain score. The planned sample size was 250 patients per group. Results: The study was halted after 295 patients were randomized because of slow enrolment and exhaustion of funding. The rate of superficial wound dehiscence was 15.2% in the early group (n = 145) versus 11.5% in the delayed group (n = 148) The point estimate for this difference (3.7 %; 95% CI -4.4 to 12.4) favours delayed removal However, because the 95% CI includes zero and the upper CI exceeds the predefined limit for non-inferiority (8%), non-inferiority was not demonstrated. The rates of all secondary outcomes were similar in the early group and the delayed group: seroma/hematoma (6.9% vs 4.7%; RR 1.4, 95% CI 0.6 to 3.7, P = 0.4); surgical site infection (9.7% vs. 4.8%; RR 2.0, 95% CI 0.8 to 4.9, P = 0.1); and composite (superficial wound dehiscence, seroma/hematoma, and surgical site infection) wound complication (17.2% vs. 12.8%; RR 1. 3, 95% CI 0.8 to 2.3, P = 0.3). Conclusion: The non-inferiority of early skin staple removal was not demonstrated. Delayed removal of staples should remain the accepted standard in the obese patient following Caesarean section.

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APA

Nuthalapaty, F. S., Lee, C. M., Lee, J. H., Kuper, S. G., & Higdon, H. L. (2013). A Randomized Controlled Trial of Early Versus Delayed Skin Staple Removal Following Caesarean Section in the Obese Patient. Journal of Obstetrics and Gynaecology Canada, 35(5), 426–433. https://doi.org/10.1016/S1701-2163(15)30933-6

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