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临床试验/NCT01049971
NCT01049971已完成不适用

Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2007年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
percentage of wound infections

研究概览

简要总结

Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery.

Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections.

This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • •elective laparoscopic colorectal resection with minilaparotomy

排除标准

  • •emergency operation
  • •patients under 18 years of age

研究组 & 干预措施

no wound protector

Active Comparator

instead of wound protector, a woven drape is applied

干预措施: no wound protector (Device)

wound protector

Experimental

after minilaparotomy, wound protector is applied

干预措施: wound protector (Device)

结局指标

主要结局

percentage of wound infections

时间窗: 6 months postoperatively

the total percentage of wound infections within 6 months postoperatively will be analyzed

次要结局

  • colonialization of abdominal wall with bacteria(6 months postoperatively)
  • postoperative costs(6 months postoperatively)
  • length of hospital stay(6 months postoperatively)
  • cosmetic result(6 months postoperatively)

研究者

申办方类型
Other

研究点 (1)

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