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.
Obstet Gynecol. 2014 Jun;123(6):1169-1175. doi: 10.1097/AOG.0000000000000227.
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.
目的:比较剖宫产术后缝合与皮钉皮肤缝合的伤口并发症发生率。
方法:这是一项在美国三家医院进行的前瞻性、随机临床试验,纳入了 2010 年至 2012 年期间妊娠 23 周或以上、经低位横行切口行剖宫产的女性。按体重指数和初次剖宫产与再次剖宫产分层后,将女性随机分为缝合或皮钉缝合皮肤切口。主要结局为伤口并发症发生率,定义为感染、血肿、血清肿、分离 1 厘米或更长、或因伤口并发症再次入院的复合结果。分析采用意向治疗原则;根据纳入的医院作为协变量,按随机分组分层,并进行调整。
结果:共纳入 746 名女性,370 名接受缝合,376 名接受皮钉缝合。中位孕龄为 39 周。58 名女性(7.8%)发生伤口并发症-缝合组 4.9%,皮钉组 10.6%(调整后的优势比[OR]0.43,95%置信区间[CI]0.23-0.78);这主要是由于两组伤口分离发生率降低(分别为 1.6%和 7.4%;调整后的 OR 0.20,95%CI 0.07-0.51)。
结论:与皮钉缝合相比,缝合缝合剖宫产皮肤切口可使伤口并发症减少 57%。
临床试验注册:Clinicaltrials.gov,www.clinicaltrials.gov,NCT01211600。
证据水平:I。
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