Assessment on the Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section. A Retrospective, Monocenter, Observational Study in Daily Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Rate of wound complications including post-cesarean section surgical site infections (SSIs)
研究概览
简要总结
The aim of this study is to collect clinical data on the use of Novosyn® applied for the uterus closure in cesarean section. Diverse parameters have been selected to assess that the safety and effectiveness of Novosyn® is comparable to published results, where the rate of SSIs in patients undergoing uterus closure in cesarean section was 10.6%.
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
- •Female patients.
- •Age ≥ 18 years
- •Patients undergoing one of the following gynaecologic surgeries:
- •scheduled (elective) cesarean section
- •cesarean section in labour
- •urgent cesarean section
- •Use of Novosyn® following routine clinical practice.
- •Patients with available electronic health records (EHR).
排除标准
- •Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
- •Participation in any clinical trial
结局指标
主要结局
Rate of wound complications including post-cesarean section surgical site infections (SSIs)
时间窗: within the first 30 days ± 10 days following cesarean delivery.
Incidence of wound complications including post-cesarean section surgical site infections (SSI). The documented infections include the following: * Organ/space surgical site infections or endometritis * Primary and secondary superficial incisional surgical site infections (involving the skin and subcutaneous tissue). * Primary and secondary deep incisional surgical site infections (involving fascial and muscle layers). * Severe complications of endometritis: septicemia, peritonitis, and septic thrombosis of the pelvic vessels.
次要结局
- incidence of post-surgery complicated wound healing(within the first 30 days ± 10 days following cesarean delivery.)
- Incidence of reoperations/readmissions(within the first 30 days ± 10 days following cesarean delivery.)
- Length of Hospital Stay(up to discharge (up to 10 days after surgery))
- Need for blood transfusion(within the first 30 days ± 10 days following cesarean delivery.)
- Incidence of Adverse device effects (ADEs)(within the first 30 days ± 10 days following cesarean delivery.)