Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.
详细描述
A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.
Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.
Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).
Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith & Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.
Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients proposed for emergency laparotomy
排除标准
- •Contra-indication for iNPWT
- •Irreversible disease diagnosis with expected short term mortality
- •Need for a staged procedure
结局指标
主要结局
Surgical site infection
时间窗: 30 days
Surgical site infection following emergency laparotomy
次要结局
- Surgical site occurrences(30 days)
研究者
Marcelo José Maia Azevedo Costa
Principal investigator, general surgery resident
Centro Hospitalar do Tâmega e Sousa
