Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Vascular Surgery Patients Undergoing Common Femoral Artery Exposure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Superficial surgical site infection
研究概览
简要总结
The purpose of this randomized clinical trial is to investigate the role of negative pressure wound therapy (NPWT) vs standard sterile gauze therapy on the incidence of surgical site infections (SSI) in primarily closed groin incisions in high risk patients undergoing any open common femoral artery exposure for a vascular surgery procedure.
详细描述
Eligible patients are randomized pre-operatively into either a standard dressing or NPWT for the groin incision.
- 1 The control group receive a standard sterile gauge dressing over the groin incision. The dressing is removed on post-operative day #2 and the wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.
- 2 The intervention group will receive a NPWT dressing which will be applied in the operating room under sterile conditions. The NPWT dressing will be removed on Post operative day 5. The wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.
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
盲法说明
As this intervention necessitated the use of an external negative wound therapy device, masking is not possible
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
- •One or more of the following
- •Body Mass Index >30 kg/m2
- •Critical limb ischemia defined by Ankle Brachial Index<0.35, rest pain, tissue loss and/or non-healing ulcers
- •Procedure time >240 min
- •End Stage Renal Disease on dialysis
- •Glycated hemoglobin ≥ 8.5%
- •Transfusion ≥ 3 units packed Red Blood Cells
- •Previous femoral artery cut-down
排除标准
- •Any of the following
- •Preexisting groin infection
- •Complete vacuum seal cannot be achieved with negative pressure device
- •Allergy to Adhesive Material
- •Groin Surgery within last 30 days
结局指标
主要结局
Superficial surgical site infection
时间窗: 30 days postoperatively
Surgical site infection as defined by the Center for disease control and prevention criteria
次要结局
- Mortality(30 days)
- Local reaction to negative wound dressing(5 days postoperatively)
- Limb Loss(30 days and 1 year)
- Emergency department visit for wound complication(within 30 days of surgery)
研究者
loay kabbani, MD
Principle Investigator
Henry Ford Health System