MOVE 试验：可吸收缝线（MonoCryl）与薇乔线（Vicryl Rapide）用于会阴侧切缝合的随机对照试验。
The MOVE-trial: Monocryl® vs. Vicryl Rapide™ for skin repair in mediolateral episiotomies: a randomized controlled trial.
机构信息
Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, The Netherlands.
Department of Obstetrics and Gynecology, Amphia Hospital, Langendijk 75, 4819 EV, Breda, The Netherlands.
出版信息
BMC Pregnancy Childbirth. 2017 Oct 16;17(1):355. doi: 10.1186/s12884-017-1545-8.
BACKGROUND
Previous studies have shown that complaints after episiotomy repair depend on the method and material used for repair. The objective of our study was to determine which of two frequently used suture materials, Monocryl® (poliglecaprone 25) and Vicryl Rapide™ (polyglactin 910), is superior for intracutaneous closure of the skin in mediolateral episiotomies.
METHODS
In a randomized controlled trial performed in a teaching hospital in the Netherlands between 2010 and 2013 250 primiparous women with uncomplicated mediolateral episiotomies were randomly allocated to intracutaneous skin closure with either Monocryl® or Vicryl Rapide™. All other layers were sutured with Vicryl 2-0 and Vicryl 0 in both groups. Pain scores and complications were documented using questionnaires during the first three months post partum. The primary outcome was pain 10 days after delivery in sitting position established by Visual Analogous Scale (VAS). Secondary outcomes were pain scores at different time points and reported complications such as infections, dehiscence and dyspareunia one day, 10 days, six weeks and three months after delivery.
RESULTS
Of 250 allocated women 54% returned questionnaires. No statistical difference was found between both groups for the primary outcome (VAS 2,8 (95% CI 2,18-3,44) vs. VAS 2,5 (95% CI 2,00-2,98), p = 0,43). With regard to secondary outcomes only self-reported dehiscence was significantly different, favouring Monocryl® (10% vs. 25%, p = 0.016).
CONCLUSIONS
Use of Monocryl® 3-0 and Vicryl Rapide™ 3-0 for intracutaneous closure of the skin after mediolateral episiotomy leads to equal pain scores ten days after delivery and therefore both materials may be considered for this use. Monocryl® 3-0 might be favourable over Vicryl Rapide™ 3-0 due to less self-reported dehiscence after intracutaneous closure of the skin in mediolateral episiotomies.
TRIAL REGISTRATION
The trial was retrospectively registered under trial nr. ISRCTN29869308 on 20-04-2016.
背景
先前的研究表明，会阴切开修复后的投诉取决于修复所使用的方法和材料。我们的研究目的是确定两种常用缝线材料（单乔®（聚己内酯 25）和薇乔快薇乔®（聚乳酸 910））中哪一种更适合会阴侧切的皮内缝合。
方法
在 2010 年至 2013 年期间，在荷兰的一家教学医院进行了一项随机对照试验，将 250 名初次分娩、无并发症的会阴侧切产妇随机分配至单乔®或薇乔快薇乔®皮内缝合。两组均使用薇乔 2-0 和薇乔 0 缝合所有其他层。在产后三个月内使用问卷调查记录疼痛评分和并发症。主要结局是采用视觉模拟评分（VAS）在产后 10 天测量的坐位疼痛。次要结局是不同时间点的疼痛评分以及产后 1 天、10 天、6 周和 3 个月报告的并发症，如感染、裂开和性交困难。
结果
在 250 名分配的妇女中，54%返回了调查问卷。两组主要结局（VAS 2.8（95%CI 2.18-3.44）与 VAS 2.5（95%CI 2.00-2.98））无统计学差异（p=0.43）。关于次要结局，只有自我报告的裂开有显著差异，单乔®组更优（10% vs. 25%，p=0.016）。
结论
在会阴侧切后使用单乔®3-0 和薇乔快薇乔®3-0 进行皮内缝合，产后 10 天的疼痛评分相同，因此两种材料均可考虑用于这种用途。由于在会阴侧切皮内缝合后，自我报告的裂开较少，单乔®3-0 可能优于薇乔快薇乔®3-0。
试验注册
该试验于 2016 年 4 月 20 日以试验编号 ISRCTN8661406 进行了回顾性注册。
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