NCT03460262Unknown不适用
Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery in High Risk Patient: a Randomized Control Study
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年3月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The rate of wound complications
研究概览
简要总结
Surgical site infection in vascular surgery is a relatively common event with reported incidence as high as 43%. When considering the groin alone, the incidence is around 20% (30% when considering any wound complication). This complication may sometimes lead to heavier complication (leg amputation, longer hospital stay, high costs...) and affects the early postoperative quality of life of the patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Every high-risk patient (meeting one of the criteria of table I) undergoing vascular surgery with groin incision (without ongoing infection)
排除标准
- •Patients who need a transverse incision before EndoVascular Aortic Repair procedure, considering that in our experience surgical site infection almost never occurs after these procedures and patients with mental incapacities.
研究组 & 干预措施
Standard dressing-Cutiplast®
Active Comparator
干预措施: Standard cutiplast® (Device)
Negative pressure wound therapy-PICO®
Experimental
干预措施: PICO® (Device)
结局指标
主要结局
The rate of wound complications
时间窗: at one year
次要结局
未报告次要终点
研究者
研究点 (2)
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