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临床试验/NCT00572507
NCT00572507已完成不适用

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

Aesculap AG8 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年12月最近更新:
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
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

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)

研究者

发起方
Aesculap AG
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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