Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Groin Wound Complication
研究概览
简要总结
The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.
详细描述
The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study
排除标准
- •Emergency procedure
- •Unable to give informed consent
研究组 & 干预措施
High Risk - Prevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
干预措施: Prevena Care (Device)
High Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
干预措施: Dry gauze dressing care (Device)
Low Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
干预措施: Dry gauze dressing care (Device)
结局指标
主要结局
Groin Wound Complication
时间窗: 30 days
Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma
次要结局
- Hospital Readmission(30 days)
- Return to Operating Room(30 days)
- Index Hospital Cost(30 days)
- Hospital Length of Stay(30 days)