NCT02762357已完成不适用
Post-Marketing Clinical Follow-up (PMCF) Study to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material for Episiotomy . A Monocenter, Prospective, Observational Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Incidence of wound dehiscence
研究概览
简要总结
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.
- •Singleton birth between 37 and 42 weeks gestation
- •Written informed consent
排除标准
- •Age< 18 years
- •Previous perineal surgery
- •Instrumental vaginal deliveries
- •Multiparous (at least 1 previous perineal delivery)
- •Episiotomy involving the anal sphincter or the rectum
- •Medical consumption that might adversely affect healing
- •Women with active infection at the time of delivery
结局指标
主要结局
Incidence of wound dehiscence
时间窗: 3 months postpartum
A dehiscence of the skin which needs surgical treatment with re-closure.
次要结局
- Incidence of Re-suturing(3 months postpartum)
- Sexual intercourse(3 months post-operatively)
- Dyspareunia(3 months post-operatively)
- Incidence of suture removal(3 months postpartum)
- Short-term perineal pain (VAS)(24h to 48h, 10 days postpartum)
- Long term perineal pain (VAS)(3 months postpartum)
- Pain in daily living (VAS)(24h and 10 days postpartum)
- Patient satisfaction with the repair (VAS)(until 3 months postpartum)
研究者
研究点 (2)
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