Air Barrier System for the Prevention of Prosthesis-related Infections
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 816
- 试验地点
- 2
- 主要终点
- Clinical incidence of surgical site infection
研究概览
简要总结
This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.
详细描述
This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis-related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision.
This research will evaluate ABS performance in a prospective, randomized, blinded multi-center trial. The surgical procedures studied will include total hip arthroplasty, trauma-related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic vascular graft procedures. Patients will be enrolled during the first two years of the study, and CDC guidelines require a one year follow-up period to monitor patients for potential prosthesis-related infections.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total hip arthroplasty;
- •Acetabular repair with instrumentation;
- •Posterior lumbar, cervical, or thoracic (up to and including 6 vertebral levels) spine fusion with instrumentation and vascular prosthetic graft implantation.
排除标准
- •History of prior prosthesis infection;
- •Active infection;
- •Open traumatic wounds as is the case after some acetabular fractures.
结局指标
主要结局
Clinical incidence of surgical site infection
时间窗: One-year post surgery
Subjects are followed for one year post-surgery for onset of prosthesis-related infections .
次要结局
未报告次要终点