Negative Pressure Wound Management (NPWT) System for Inguinal Wounds After Venous Hybrid Procedures
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy
研究概览
简要总结
All patients with deep venous obstruction below the sapheno-femoral junction elective for hybrid procedure with creation of an arterio venous-fistula (AVF) in the MUMC or patients with primary percutaneous procedure (and thus venous obstruction above the sapheno-femoral junction) who present with occluded stents which need an additional AVF after thrombolysis will receive a Prevena NPWT. Incidence of wound infections and wound scoring will be performed afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with deep venous obstruction below the sapheno-femoral junction primary elective for hybrid procedure with creation of an AV-fistula in the MUMC
- •Be able to communicate in Dutch
- •Life expectancy >1 year
排除标准
- •Patients with allergies for the components of the used negative pressure incision management system (Prevena)
结局指标
主要结局
Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy
时间窗: 3 months
Patients will be prospectively followed and checked for development of wound infections (grade 1-5). Therapy to treat the infections will be monitored.
次要结局
未报告次要终点