A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Proportion of postoperative incision complications between the 2 arms
研究概览
简要总结
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
详细描述
Incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. This research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. Negative pressure wound therapy is commonly used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. Currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure wound therapy and standard dressings in 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
- 是
入选标准
- •Must be at least 18 years or older to participate.
- •Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).
- •Has at least one artery that feeds the closure site.
- •Able to comply with clinical trial procedures and schedule.
排除标准
- •Patients not receiving an amputation.
- •The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating.
- •Surgical incision that is not completely closed.
研究组 & 干预措施
Group A: Standard Dry Dressing
The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.
干预措施: Standard Dry Dressing (Other)
Group B: Foam, Drape, and PrevenaTM
This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.
干预措施: PrevenaTM Device (Device)
结局指标
主要结局
Proportion of postoperative incision complications between the 2 arms
时间窗: 95 days
The proportion of issues that arise between the two groups after closure surgery.
次要结局
- Length of hospital stay(5 days)
- Number of surgically related wound readmissions(95 days)
- Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge(At 1, 2, and 3 months post-hospital discharge)
- Medical Outcomes Study 12 Short Form Health Survey (SF-12)(95 days)
研究者
Christopher Attinger, M.D.
Associate Professor
Georgetown University