A Historically-controlled Single-arm Multi-center Prospective Trial to Evaluate the Safety and Efficacy of Aesculap MonoMax® Suture Material for Abdominal Wall Closure After Primary Median Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy
研究概览
简要总结
MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in the INSECT trial. The secondary objectives are to demonstrate that the length of postoperative hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or lower than in the INSECT trial. [Knaebel HP et al., 2005]
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age equal or greater than 18 years
- •Expected survival time > 12 months
- •Patient undergoing elective and primary median laparotomy
- •BMI < 35
- •Expected length of skin incision > 15 cm
排除标准
- •Peritonitis
- •Emergency surgery
- •Coagulopathy
- •Current immunosuppressive therapy (> 40 mg of a Corticoid per day or Azathioprin)
- •Chemotherapy within 2 weeks before operation
- •Radiotherapy of the abdomen completed less than 8 weeks before operation
结局指标
主要结局
frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy
时间窗: till day of discharge
次要结局
- length of postoperative hospital stay after surgery and frequency of incisional hernias 12 months after the surgery and frequency of wound infections 30 days postoperative(different)
