'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 2,998
- 试验地点
- 4
- 主要终点
- Frequency of surgical site infection (superficial (A1) and deep (A2)
研究概览
简要总结
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
- •Written informed consent
- •Age≥ 18 years
- •Not incapacitated patient
排除标准
- •No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine
研究组 & 干预措施
Polyglactin 910
Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine
干预措施: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery (Device)
Novosyn®
Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine
干预措施: Novosyn® in emergency or elective laparotomy or laparoscopic surgery (Device)
结局指标
主要结局
Frequency of surgical site infection (superficial (A1) and deep (A2)
时间窗: until 30 days + 5 days after surgery.
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2).
次要结局
- Length of hospital stay(until discharge (approximately 10 days after surgery))
- Handling of the suture material(intraoperatively)
- Incidence of Surgical Site Infection (SSI)(at discharge (approximately 10 days after surgery))
- Cumulative Rate of Re-suturing(at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.)
- Cumulative Rate of reoperation(at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.)
- Time to return to work(until 30 days + 5 days after surgery.)
- Cumulative Rate of suture removal due to wound problems(at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.)
- Hernia rate(30 days + 5 days postoperatively)
- Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class(until 30 days + 5 days after surgery)
- Cumulative Rate of postoperative complications(discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.)