OBJECTIVE: To compare the incidence of wound complications between suture and staple skin closure after cesarean delivery.
METHODS: This prospective, randomized clinical trial conducted at three hospitals in the United States between 2010 and 2012 included women undergoing cesarean delivery at 23 weeks of gestation or greater through a low-transverse skin incision. Women were randomized to closure of the skin incision with suture or staples after stratifying by body mass index and primary compared with repeat cesarean delivery. The primary outcome was incidence of wound complications, predefined as a composite of infection, hematoma, seroma, separation of 1 cm or longer, or readmission for wound complications. Analysis was according to the intention-to-treat principle; results were stratified by randomization group and adjusted for hospital by including it as a covariate.
RESULTS: A total of 746 women were randomized, 370 to suture and 376 to staple closure. The median gestational age was 39 weeks. Fifty-eight women (7.8%) had wound complications—4.9% in the suture group and 10.6% in the staple group (adjusted odds ratio [OR] 0.43, 95% confidence interval [CI] 0.23–0.78); this was largely the result of the decreased incidence of wound separation in the respective groups (1.6% compared with 7.4%; adjusted OR 0.20, 95% CI 0.07–0.51).
CONCLUSIONS: Suture closure of the skin incision at cesarean delivery is associated with a 57% decrease in wound complications compared with staple closure.
CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01211600.
LEVEL OF EVIDENCE: I
Suture closure of the skin incision at cesarean delivery is associated with a 4.9% wound complication rate compared for 10.6% with staple closure.
Departments of Obstetrics and Gynecology, Geisinger Health System, Danville, Lankenau Medical Center, Wynnewood, and Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, and Yale-New Haven Hospital, New Haven, Connecticut; and the Division of Biostatistics, Thomas Jefferson University, Philadelphia, Pennsylvania.
Corresponding author: A. Dhanya Mackeen, MD, MPH, 100 North Academy Avenue, Danville, PA 17822; e-mail: email@example.com.
* For a list of other members of the CROSS Consortium, see Appendix 1 online at http://links.lww.com/AOG/A484.
Supported by Ethicon, Inc. After the study was designed and initiated, Ethicon, Inc agreed to provide funds to assist with patient recruitment and follow-up. The funding source had no influence on study design, study execution, data analysis, or publication.
The authors thank Louis Weinstein, MD, for study design; Susan Weiner, PhD, Diane Mauro Donohue, CRNP, Jacqueline Fishbein, CRNP, Padmini Manrai, BS, Tanya Puklus, BS, Kristina Wihbey, BS, Daniel Bercik, BS, Kaitlyn Edelson, MD, Jacqueline Kohl, MD, and Eliza Fradkin, BS, for data collection and conduct of the clinical trial; and Sandy M. Field, PhD, for medical writing assistance.
Financial Disclosure The authors did not report any potential conflicts of interest.