Suture vs Staples for Skin Closure After Liver Resection
A Randomised Controlled Trial to Compare Subcuticular Suture vs Staples for Skin Closure After Liver Resection.
Closure of the skin after liver resection (surgery to remove part of the liver) may be achieved by one of several methods. The standard method at our institution is to use stainless steel staples to adjoin the two sides of skin. Alternatively, a continuous absorbable suture may be used to "sew" the skin together.
The ideal method of closure should be safe, effective, associated with minimal patient discomfort and have a good cosmetic result. At present, there is no scientific evidence to describe which method is most suitable following liver resection.
The primary aims of this study is to investigate which method (subcuticular sutures vs staples) offers the best result in postoperative rate of (1) skin infection, (2) skin dehiscience (separation of skin) and (3) time taken to perform skin closure. In addition, we are interested in which method is best for patient satisfaction and cosmetic appearance and which method is most cost effective.
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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Leeds、英国、LS9 7TF
- Leeds Teaching Hospital NHS Trust
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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:
- All patients undergoing liver resection surgery for benign or malignant aetiology
- All patients undergoing surgery as a living liver donor.
Exclusion Criteria:
- Any patient with an active wound infection
- Any patient with an active incisional wound hernia from previous surgery
- Synchronous bowel/liver surgery
- History of keloid formation
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:Staple Group
Staple Group: At the end of the operation, the skin will be closed using stainless steel staples, which is standard clinical practice at St. James's University Hospital.
Approximately ten days after the operation, the staples will be manually removed; this is normally performed by the patients GP.
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实验性的:Suture Group
Suture Group: At the end of the operation, the skin will be closed using absorbable surgical suture.
Manual removal of this suture is not required because the thread is self-absorbable.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Post-operative infection time
大体时间:1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Time taken for skin closure
大体时间:12 months
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12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- GS13/10722
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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