Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 3
- 主要终点
- Overall Rate of Wound Complications
研究概览
简要总结
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.
详细描述
This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™ Dressing Kit) on incidence of post-operative wound complications in patients undergoing above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately five (5) participating sites will be randomized to receive either the Prevena dressing or a standard care dressing. The incision will be assessed for complications at post-op day 5 or day 6 and at approximately 30 days after discharge. The primary outcome of this study is reported wound complications, including dehiscence (opening of the incision), seroma, lymph leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood supply), and necrosis (tissue death) A major complication is defined as any wound complication requiring intravenous or oral antibiotics, reoperation and/or hospital readmission. All data (demographics, medical history, and clinical outcomes) will be collected via medical record review
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female adults 18 years or older
- •Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
- •Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
- •Informed Consent signed by patient
排除标准
- •Minors under 18 years
- •Women who are pregnant or breastfeeding
- •Patients undergoing emergent or guillotine amputation
- •Patients having BOTH legs amputated
- •Patients with sensitivity to silver
- •Unwilling or unable to provide informed consent
- •Inability to comply with planned study procedures
研究组 & 干预措施
Prevena
PREVENA™ PEEL & PLACE™ Dressing Kit
干预措施: PREVENA™ PEEL & PLACE™ Dressing Kit (Device)
Standard Care
sterile gauze dressing supplemented with an Ace wrap
结局指标
主要结局
Overall Rate of Wound Complications
时间窗: 30 days post procedure
Presence of any of the following post-procedure: * Dehiscence (skin or fascia) * Seroma * Lymph leak * Infection (superficial or deep, using CDC Surgical Site Infection criteria) * Hematoma * Ischemia * Necrosis
次要结局
- 30-day Return to Operating Room (ROR)(30 days post procedure)
- Length of Stay (LOS)(30 days post procedure)
- 30-day Hospital Readmissions(30 days post procedure)
- Incidence of Skin Dehiscence(30 days post procedure)
- Incidence of Fascial Dehiscence(30 Days)
- Incidence of Superficial Skin Infection(30 days)
- Incidence of Deep Skin Infection(30 days)
- Incidence of Seroma(30 Days)
- Incidence of Hematoma(30 days)
- Incidence of Necrosis(30 Days)