REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors (REDWIL)
Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Berlin、德国、12200
- Charité Campus Benjamin Franklin; Hindenburgdamm 30
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- elective laparoscopic colorectal resection with minilaparotomy
Exclusion Criteria:
- emergency operation
- patients under 18 years of age
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:no wound protector
instead of wound protector, a woven drape is applied
|
use of woven drape instead of wound protector
|
|
实验性的:wound protector
after minilaparotomy, wound protector is applied
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after minilaparotomy, the wound protector is applied
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
percentage of wound infections
大体时间:6 months postoperatively
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the total percentage of wound infections within 6 months postoperatively will be analyzed
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6 months postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
colonialization of abdominal wall with bacteria
大体时间:6 months postoperatively
|
a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed
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6 months postoperatively
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postoperative costs
大体时间:6 months postoperatively
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the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed
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6 months postoperatively
|
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length of hospital stay
大体时间:6 months postoperatively
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the total hospital stay including re-admissions is analyzed
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6 months postoperatively
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cosmetic result
大体时间:6 months postoperatively
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the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively
|
6 months postoperatively
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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