Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 10
- 主要终点
- Primary fascial closure rate
研究概览
简要总结
The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.
详细描述
Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. A novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients.
In this multicenter study we prospectively evaluate the technique.
Inclusion criteria:
All patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with VAWC and mesh mediated fascial traction will be included in the study in an intention to treat model.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •open abdomen patients with midline incisions, where vacuum assisted wound closure system and mesh mediated fascial traction is applicable
排除标准
- •open abdomen patients treated otherwise
结局指标
主要结局
Primary fascial closure rate
时间窗: 2 months
Primary fascial closure rate with the technique
次要结局
- Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development(5 years)
研究者
Ulf Petersson
MD, PhD, Ass prof
Skane University Hospital