Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol - A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Fascial Closure Rate
研究概览
简要总结
The open abdomen is a valid and accepted surgical tactic for the trauma and acute care patient. There have been many mechanisms described for its management, but the most accepted strategy is the vacuum pack. At our hospital the investigators have used for many years a double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation. At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the investigators try to tighten the mesh with sutures until the abdomen can be closed. This study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to determine which is related to a higher fascial closure rate.
详细描述
The Investigators plan to compare our double sylo-mesh protocol with the vacuum pack technique described by Barker et al. To accomplish this they have designed a randomized trial that will include patients that require an open abdomen strategy according to their attending physician either due to a traumatic or a medical cause. Once the surgeon decides to leave the abdomen open, one of the nurses will pick up an envelope from the randomization box and read out loud the patients allocation (Vacuum pack or Double sylo bag-mesh protocol) . During subsequent surgeries the patient must continue with the same strategy for a minimum of 21 days or until fascial closure. The patients will be followed during their whole hospital stay to determine complication rates and fascial closures.
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
- 13 Years 至 96 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Open Abdomen
排除标准
- •Patients that die in the first 48 hours after the initial intervention
结局指标
主要结局
Fascial Closure Rate
时间窗: Until hospital discharge Aprox 60 days
次要结局
- Gastrointestinal Fistulas(Until hospital discharge Aprox. 60 days)
- Day of Fascial Closure(Until hospital discharge Aprox. 60 days)
- Length of Stay(Until hospital discharge Aprox. 60 days)
- Abdominal Abscess(Until hospital discharge Aprox. 60 days)
- Fascial Closure Dehiscence(Until hospital discharge Aprox. 60 days)
研究者
Carlos Hernando Morales
Chief Surgery Department
Universidad de Antioquia