Experience With the Negative Pressure Incision Management System (Prevena) in Vascular Surgery Patients With High Risk for Groin Wound Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- % of infection at 30 days
研究概览
简要总结
Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.
详细描述
Patients submitted to bilateral femoral endarterectomy will have one groin dressed with PrevenaTM and the contralateral one dressed with conventional bandage immediately after suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed before the patient discharge. Groin wound complications such as deep space infection, cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be observed in a 30-day evaluation window. This observation will be performed during the patient admission and in the post-operative standard of care visits among the first 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known bilateral vascular peripheral disease who are being evaluated for possible bilateral femoral endarterectomy
- •Patients with one or more risk factor (diabetes mellitus, Obesity, heavy smoker, immunodeficiency disease, groin reoperation, prosthetic)
- •Patients in follow-up at Clinic in the Vascular Surgery Department
- •Sign of informed consent
- •English speaking
排除标准
- •Refusal to participate
- •pregnancy
- •unilateral femoral endarterectomy
- •subjects for whom Prevena IMS is contraindicated
结局指标
主要结局
% of infection at 30 days
时间窗: 30 days
% of wound occurrence in the Prevena treated groin compared to conventional treated groin
次要结局
未报告次要终点
研究者
Levester Kirksey
MD
The Cleveland Clinic