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Abstract：
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.
BACKGROUND: The trial was retrospectively registered under trial nr. ISRCTN29869308 on 20-04-2016.
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.
BACKGROUND: The trial was retrospectively registered under trial nr. ISRCTN29869308 on 20-04-2016.
摘要：
背景：先前的研究表明，会阴切开术修复后的主诉取决于用于修复的方法和材料。我们研究的目的是确定两种常用的缝合材料中的哪一种，Monocryl®（poliglecaprone25）和VicrylRapide™（polyglactin910），在中外侧上皮切开术中，皮内闭合皮肤的优势。
方法：在2010年至2013年在荷兰一家教学医院进行的一项随机对照试验中，将250名患有无并发症的中外侧切开的初产妇随机分配给Monocryl®或VicrylRapide™进行皮内皮肤闭合。两组中的所有其他层都用Vicryl2-0和Vicryl0缝合。产后前三个月使用问卷记录疼痛评分和并发症。主要结果是通过视觉类比量表（VAS）确定的坐姿分娩后10天疼痛。次要结果是不同时间点的疼痛评分和报告的并发症，如感染，有一天会裂开和性交困难，10天,分娩后六周三个月。
结果：在250名分配的妇女中，有54％的人返回了问卷。两组之间的主要结局无统计学差异（VAS2,8（95％CI2,18-3,44）与VAS2,5（95%CI2,00-2,98），p=0,43）。关于次要结局，只有自我报告的裂开存在显着差异，偏爱Monocryl®(10%与25%,p=0.016)。
结论：使用Monocryl®3-0和VicrylRapide™3-0在会阴侧切开术后的皮内闭合皮肤会导致分娩后十天疼痛评分相等，因此两种材料均可考虑用于此用途。Monocryl®3-0可能优于VicrylRapide™3-0，因为在中外侧外切开术中，皮内闭合皮肤后自我报告的裂开较少。
背景：该试验在试验nr下进行回顾性注册。ISRCTN29869308on20-04-2016.
方法：在2010年至2013年在荷兰一家教学医院进行的一项随机对照试验中，将250名患有无并发症的中外侧切开的初产妇随机分配给Monocryl®或VicrylRapide™进行皮内皮肤闭合。两组中的所有其他层都用Vicryl2-0和Vicryl0缝合。产后前三个月使用问卷记录疼痛评分和并发症。主要结果是通过视觉类比量表（VAS）确定的坐姿分娩后10天疼痛。次要结果是不同时间点的疼痛评分和报告的并发症，如感染，有一天会裂开和性交困难，10天,分娩后六周三个月。
结果：在250名分配的妇女中，有54％的人返回了问卷。两组之间的主要结局无统计学差异（VAS2,8（95％CI2,18-3,44）与VAS2,5（95%CI2,00-2,98），p=0,43）。关于次要结局，只有自我报告的裂开存在显着差异，偏爱Monocryl®(10%与25%,p=0.016)。
结论：使用Monocryl®3-0和VicrylRapide™3-0在会阴侧切开术后的皮内闭合皮肤会导致分娩后十天疼痛评分相等，因此两种材料均可考虑用于此用途。Monocryl®3-0可能优于VicrylRapide™3-0，因为在中外侧外切开术中，皮内闭合皮肤后自我报告的裂开较少。
背景：该试验在试验nr下进行回顾性注册。ISRCTN29869308on20-04-2016.
