NCT00940979终止不适用
Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
Rijnstate Hospital3 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2010年1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
- 终止
- 发起方
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- Postoperative wound infections
研究概览
简要总结
The purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of Integuseal for vascular procedures on lower extremities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft
排除标准
- •secondary procedures and suprainguinal procedures
研究组 & 干预措施
No use of integuseal
No Intervention
Use of Integuseal
Experimental
Application of a layer of Integuseal (Cyanoacrylate) from a ready to use applicator preoperative before incision Polymerisation immobilise the bacteria that survived the conventional skin preparation This way there will be les contamination of the wound.
干预措施: Application of Integuseal sealant (Procedure)
结局指标
主要结局
Postoperative wound infections
次要结局
- Costs of the use of Integuseal
- Complications during hospital stay
研究者
研究点 (3)
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