Reduction of Groin Wound Infections After Vascular Surgery in Patients With Risk Factors by the Use a Negative Pressure Wound Incision Management System (KCI Prevena)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 4
- 主要终点
- wound infections
研究概览
简要总结
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
详细描述
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
The aim is to demonstrate that the application of the Prevena™ IMS significantly reduces the incidence of postoperative wound infections. The wound infections will be classified according to Szilagyi.
The treatment phase begins following vascular surgery with wound management using either the Prevena™ IMS or a standard wound dressing, depending on the group to which the patient was randomly assigned. It involves a minimum stay of 7 and maximum 10 days in hospital.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vascular surgery via right or left inguinal approach
- •nicotine abuse (active or according to medical condition)
- •risk factors:
- •cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)
- •metabolic disorders (diabetes mellitus type I type II, lipopathy or hyperhomocysteinemia) or chronic or acute renal insufficiency
- •previous vascular surgery with inguinal approach
- •signed informed consent form
- •persons who are legally competent and mentally able to comprehend and follow the instructions of study personnel
排除标准
- •local skin infections (fungal infections, acne)
- •pregnant and breast-feeding women
- •simultaneous participation in another clinical trial
- •persons who have been committed to an institution by court or administrative order
- •persons in a dependency or employment relationship with the sponsor or investigator
研究组 & 干预措施
Prevena™ IMS
The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery
干预措施: Prevena™ IMS (Device)
sterile plaster dressings
The wound will be treated with the conventional wound management method of sterile plaster dressing.
干预措施: sterile plaster dressings (Other)
结局指标
主要结局
wound infections
时间窗: 7 days after the surgery
The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.
次要结局
- length of hospital stay(up to 10 days)
- antibiotic therapy(up to 30 days)
- revision surgery(up to 30 days)
- necessity of alternative wound dressings(up to 30 days)
- prolongation of ambulant treatment(up to 30 days)