NCT00834314终止不适用
Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With "Vacuum-Pack"-Technique vs. "Abdominal Dressing"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)
研究概览
简要总结
The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen.
Secondary purpose is the comparison of feasibility and economic aspects.
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
- 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
- 否
入选标准
- •Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible
排除标准
- •Technical reasons
- •unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique
研究组 & 干预措施
Abdominal dressing
Active Comparator
see Interventions
干预措施: Abdominal-dressing-technique for temporary abdominal closure (Procedure)
Vacuum-pack
Experimental
see Interventions
干预措施: Vacuum-Pack-technique for temporary abdominal closure (Procedure)
结局指标
主要结局
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)
时间窗: until end of vacuum-therapy or death
次要结局
- vacuum-therapy-related morbidity/complications(until hospital dismissal or death)
- total length of ICU-stay(until end of ICU-therapy or death)
- post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)(12 weeks after hospital dismissal)
- length of vacuum-therapy(until end of vacuum-therapy or death)
- costs of vacuum-therapy(until end of vacuum-therapy or death)
- recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay(12 weeks post hospital dismissal)
研究者
Prof Dr. Stefan Post
Prof. Dr., Director of Surgical Department
Universitätsmedizin Mannheim
研究点 (2)
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