University of São Paulo, School of Arts, Sciences and Humanities, São Paulo, São Paulo, Brazil.
University of São Paulo, School of Arts, Sciences and Humanities, São Paulo, São Paulo, Brazil.
Women Birth. 2021 Sep;34(5):e514-e519. doi: 10.1016/j.wombi.2020.09.018. Epub 2020 Oct 16.
Surgical glue has been indicated for uncomplicated operatory wounds; however, it has a considerable cost. Non-surgical glue, a commercially available and cheaper product, has not been studied for repairing postpartum lacerations.
To compare non-surgical glue to traditional sutures on perineal first-degree lacerations after normal birth.
In a prospective, open-label, non-inferiority, randomised controlled trial, we selected childbearing women who were admitted for normal term births and in whom skin lacerations occurred. They were assigned to laceration repair using either non-surgical glue (ethyl 2-cyanoacrylate; Glue group) or catgut sutures (Suture group). The primary endpoint was the occurrence of dehiscence >3mm. Secondary endpoints were procedure runtime, pain score, satisfaction level, and aspects of perineal repair by the REEDA score (hyperaemia, oedema, ecchymosis, exudation, and coaptation) immediately (T0), 24-48h (T1), and 7-10 days (T2) after childbirth.
We included 126 women, 63 in each group, and found a non-inferiority dehiscence rate in the Glue Group compared to the Control group (T1=1.6% vs. 1.6%, P=0.999 and P<0.001 for non-inferiority; and T2=2.2% vs. 4.3%, P=0.557). In the Glue Group, the procedure runtime was shorter, pain score was lower, and women's satisfaction was greater. No women had any allergic reaction in the study.
Non-surgical glue was not inferior to traditional sutures to repair postpartum first-degree lacerations. In addition, non-surgical glue was associated with less pain and greater satisfaction. Brazilian Clinical Trials Registry (www.ensaiosclinicos.gov.br/rg/RBR-5Z8MKC).
手术胶已被用于简单的手术伤口，但成本较高。非手术胶是一种商业上可获得的、更便宜的产品，尚未被研究用于修复产后裂伤。
比较非手术胶与传统缝线在正常分娩后会阴一度裂伤的修复效果。
在一项前瞻性、开放标签、非劣效性、随机对照试验中，我们选择因正常足月分娩而入院的产妇，这些产妇发生了皮肤裂伤。她们被分配到使用非手术胶（乙基 2-氰基丙烯酸酯；胶组）或肠线缝合（缝合组）修复裂伤。主要终点是出现>3mm 的裂开。次要终点是手术时间、疼痛评分、满意度水平，以及产后即刻（T0）、24-48 小时（T1）和 7-10 天（T2）时通过 REEDA 评分（充血、水肿、瘀斑、渗出和贴合）评估的会阴修复情况。
我们纳入了 126 名女性，每组 63 名，发现胶组的裂开率与对照组无差异（T1=1.6%对 1.6%，P=0.999 和 P<0.001 为非劣效性；T2=2.2%对 4.3%，P=0.557）。在胶组中，手术时间更短，疼痛评分更低，女性满意度更高。研究中没有女性出现任何过敏反应。
非手术胶在修复产后一度裂伤方面并不逊于传统缝线。此外，非手术胶与疼痛减轻和更高的满意度相关。巴西临床试验注册中心（www.ensaiosclinicos.gov.br/rg/RBR-5Z8MKC）。
