EFFECTS OF PREVENA THERAPY ON REDUCTION OF GROIN SURGICAL SITE INFECTIONS IN OBESE PATIENTS UNDERGOING VASCULAR SURGERY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- number of patients with infections
研究概览
简要总结
The purpose of the study is to determine the effects of Prevena therapy on decreasing groin surgical site infections in patients who are obese and /or diabetic having vascular surgery.
详细描述
Patients who are obese and/or diabetic may have poor surgical healing and infection rates higher. The PREVENA therapy will be used to evaluate possible reduction of infection rates in this patient population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects over 18 years old
- •obese (BMI > 30) and or diabetic
排除标准
- •current infected surgical field, hemodialysis, immunosuppressive therapy, allergy to adhesive, sensitivity to silver
研究组 & 干预措施
negative pressure dressing vs. standard of care
single arm study- randomized Prevena vac or standard of care
干预措施: Prevena vac (Device)
结局指标
主要结局
number of patients with infections
时间窗: 30 day post surgical procedure
reduction of 30 day surgical site infection by evaluating infection rates in obese, diabetic patients who were randomized to Prevena Vac vs. standard of care
次要结局
- infection rates(1 year)
研究者
Dr. Jean E. Starr, MD
Vascular surgeon
Ohio State University