NCT05233527进行中（未招募）不适用
Observational, Retrospective, Monocentric Clinical Study on the Safety of Novosyn® Quick in Women With a Spontaneous Vaginal Delivery Who Required an Indicated Episiotomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Aesculap AG
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Wound dehiscence rate
研究概览
简要总结
Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.
详细描述
The study design is a retrospective, consecutive series of women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.
All women treated with Novosyn® Quick between January 2020 - December 2020 at the Hospital General de Catalunya will be analyzed. The investigator team will access medical records for the cohort of patients identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Women who underwent an indicated episiotomy between January 2020 - December 2020 at the Hospital General de Catalunya (Sant Cugat del Vallès, Spain) and received Novosyn® Quick
排除标准
- •No exclusion criteria have been set
结局指标
主要结局
Wound dehiscence rate
时间窗: up to 1 month postpartum
A dehiscence of the wound which needs surgical treatment with re-closure.
次要结局
- Rectovaginal fistula(up to 1 month postpartum)
- Long-term perineal pain (VAS)(up to 1 month postpartum)
- Rate of Re-suturing(up to 1 month postpartum)
- Surgical Site Infection rate(up to 1 month postpartum)
- Abscess formation(up to 1 month postpartum)
- Short-term Pain in daily living (VAS)(24-48 hours postpartum)
- Hematoma(up to 1 month postpartum)
- Short-term perineal pain (VAS)(after 48 hours postpartum)
- Rate of Suture removal due to wound problems(up to 1 month postpartum)
- Bleeding(up to 1 month postpartum)
- Long-term Pain in daily living (VAS)(up to 1 month postpartum)
研究者
研究点 (2)
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