Prophylactic Application of an Incisional Wound Vac to Prevent Wound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Count of Patients With Post Operative Infection
研究概览
简要总结
This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications.
The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.
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
- •Be scheduled to have posterior spine surgery (inpatient procedures only).
- •Have a BMI greater than or equal to 35.
排除标准
- •BMI less than 35
- •Previous spine infection
- •Intraoperative dural tear
结局指标
主要结局
Count of Patients With Post Operative Infection
时间窗: 6 weeks post surgery
Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics
次要结局
未报告次要终点
研究者
Rakesh Patel
Clinical Assistant Professor, Orthopaedic Surgery
University of Michigan