Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
研究概览
简要总结
Groin incisions in vascular surgery have complications in up to 30% of cases at 30 days, resulting in reductions in patient quality of life and increased costs. Prior attempts at reducing this complication rate have been largely unsuccessful. The purpose of this study is to determine the feasibility of routine Vialize use for vascular surgeries involving a groin incision and to determine the rates of surgical site infection/dehiscence in such patients receiving subcutaneous Vialize.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •The study population will consist of patients undergoing vascular procedures with groin incisions. Patients must be at least 18- years-old and able to complete baseline measurements. All subjects will be compensated. Patients undergoing treatment for peripheral arterial disease (e.g., femoropopliteal bypass), aneurysm disease (e.g., aortofemoral bypass), end-stage kidney disease (e.g., loop thigh graft), and miscellaneous procedures (e.g., femoral exposure for delivery of device) will be eligible.
排除标准
- •Patients undergoing use of negative pressure wound therapy (e.g., Prevena) and local antibiotic placement (e.g., vancomycin powder) will be excluded. Additionally, organ-transplant recipients will be excluded.
研究组 & 干预措施
Vialize
Vialize is a lyophilized dehydrated complete human placental membrane allograft.
干预措施: Vialize (Other)
结局指标
主要结局
The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
时间窗: 90-day post-op follow-up
Aim 1
次要结局
- return to OR for groin infection(90-day post-op follow-up)
- Readmission or prolongation of the index admission for groin infection(90-day post-op follow-up)
- The patient quality of life (EQ-5D)(90-day post-op follow-up)