Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,869
- 试验地点
- 1
- 主要终点
- Wound Infection After Open Heart Surgery
研究概览
简要总结
This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.
详细描述
Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Transplant patients
- •Type I (insulin-dependent) diabetics
- •Severe chronic obstructive pulmonary disease (COPD)
- •Steroid-dependent patients
- •Previous Tracheostomy
排除标准
- •Thoracotomy
研究组 & 干预措施
Prospective group
Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
干预措施: Prevena Incision Management System (Device)
Retrospective arm
Conventional sterile dry wound dressing applied immediately postoperatively.
干预措施: Conventional sterile dry wound dressing (Other)
结局指标
主要结局
Wound Infection After Open Heart Surgery
时间窗: 30 days post-surgery
The total number of participants with surgical site infections after cardiac surgery.
次要结局
- Reoperation for Wound Infection(30 days post surgery)
研究者
Hartzell V. Schaff
Professor of Surgery
Mayo Clinic