Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 352
- 试验地点
- 8
- 主要终点
- Complication composite outcome
研究概览
简要总结
This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision >3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.
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
- 否
入选标准
- •All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.
- •We define high-risk fractures as those that are either:
- •Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved;
- •Any open type I, II or IIIA fracture, regardless of timing of definitive treatment;
- •Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed
- •Requiring incision for fixation or debridement of 3 cm or greater.
- •Patients 18 years of age or older
排除标准
- •The study injury is already infected at time of study enrollment.
- •Patient is unable to receive incisional NPWT for any reason.
- •Patients who have already had definitive fixation prior to enrollment in the study.
- •Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).
- •The study injury is a Gustilo Type IIIB or IIIC open fracture.
研究组 & 干预措施
Standard of Care Wound Care
Patients randomized to the control group will receive standard wound care.
Incisional Negative Pressure Wound Therapy (NPWT)
Patients randomized to the treatment group will receive wound care which includes the application of an incisional negative pressure wound vacuum.
干预措施: Incisional Negative Pressure Wound Therapy (NPWT) (Device)
结局指标
主要结局
Complication composite outcome
时间窗: 3 months
The primary outcome will be a composite outcome. We will hierarchically assess the components of the composite outcome in the following order: (1) all-cause mortality, (2) injury-related amputation of the lower extremity, (3) number of surgeries to treat a deep or organ space infection (CDC criteria), (4) wound healing complications requiring reoperation, (5) nonoperative wound necrosis at 2 or 6 weeks, wound dehiscence at 2 or 6 weeks or superficial infection (CDC criteria), (6) SCAR-Q Symptom Scale, (7) SCAR-Q Appearance Scale
次要结局
未报告次要终点