皮下缝合类型在剖宫产术后皮肤缝合中的比较：一项随机对照试验。

Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial.

机构信息

Department of Obstetrics & Gynecology and Women's Health and the Department of Anesthesiology, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.

出版信息

Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.

DOI:10.1097/AOG.0000000000002200

PMID:28796687

Abstract

OBJECTIVE

To compare the rate of wound complications among women who underwent cesarean delivery through a Pfannenstiel skin incision followed by subcuticular closure with either poliglecaprone 25 suture or polyglactin 910 suture.

METHODS

Patients undergoing nonemergent cesarean delivery at or beyond 37 weeks of gestation were randomized to undergo subcuticular skin closure with either poliglecaprone 25 or polyglactin 910. The primary outcome was a wound composite outcome of one or more of the following: surgical site infection, wound separation, hematoma, or seroma within the first 30 days postpartum. To detect a reduction in the primary outcome rate from 12% to 4%, with a power of 0.90 and a two-tailed α of 0.05, 237 women per study group were required. Analysis was performed according to the intent-to-treat principle.

RESULTS

From May 28, 2015, to August 5, 2016, 275 women were randomized to poliglecaprone 25 and 275 to polyglactin 910, of whom 520 (95%) were included in the final analysis: 263 in the poliglecaprone 25 group [of whom 231 (88%) actually underwent poliglecaprone 25 closure) and 257 in the polyglactin 910 group [of whom 209 (81%) actually underwent polyglactin 910 closure]. The groups were similar in demographic characteristics, medical comorbidities, and perioperative characteristics. Poliglecaprone 25 was associated with a significantly decreased rate of overall wound complications when compared with polyglactin 910, 8.8% compared with 14.4% (relative risk 0.61, 95% CI 0.37-0.99; P=.04).

CONCLUSION

Closure of the skin after cesarean delivery with poliglecaprone 25 suture decreases the rate of wound complications compared with polyglactin 910 suture.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT02459093.

摘要

目的

比较经皮内缝合行剖宫产术的女性中，使用聚己内酯 25 缝线或聚乳酸 910 缝线行皮下单层缝合的切口并发症发生率。

方法

在妊娠 37 周及以上的非紧急剖宫产患者中，随机分为聚己内酯 25 缝线或聚乳酸 910 缝线皮下单层缝合。主要结局是产后 30 天内出现以下一种或多种情况的伤口综合结局：手术部位感染、伤口分离、血肿或血清肿。为了检测主要结局发生率从 12%降低至 4%，需要每组 237 例患者，研究具有 0.90 的效能和双侧 0.05 的 α 值。分析按照意向治疗原则进行。

结果

2015 年 5 月 28 日至 2016 年 8 月 5 日，275 名女性被随机分配至聚己内酯 25 缝线组，275 名女性被分配至聚乳酸 910 缝线组，其中 520 名（95%）纳入最终分析：聚己内酯 25 缝线组 263 名（其中 231 名实际行聚己内酯 25 缝线缝合），聚乳酸 910 缝线组 257 名（其中 209 名实际行聚乳酸 910 缝线缝合）。两组在人口统计学特征、合并症和围手术期特征方面相似。与聚乳酸 910 缝线相比，聚己内酯 25 缝线显著降低了总伤口并发症的发生率，分别为 8.8%和 14.4%（相对风险 0.61，95%CI 0.37-0.99；P=0.04）。