Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 2 期
- 主要终点
- The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
研究概览
简要总结
This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages: 18 to 80
- •Males- not involved in active military duty.
- •Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
排除标准
- •Active systemic or local infection.
- •History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
- •Active autoimmune disease.
- •Any past or present immunosuppressive treatment.
- •Current treatment with chemotherapeutic agents
- •History of metabolic bone disease (primary or secondary).
- •Chronic renal insufficiency (defined by 50% increase of normal levels).
研究组 & 干预措施
Negative Pressure Wound Therapy (NPWT)
干预措施: Negative Pressure Wound Therapy (NPWT) (Device)
standard prophylactic therapy
干预措施: standard prophylactic therapy (Drug)
结局指标
主要结局
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
时间窗: six weeks
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
次要结局
- 1. To assess the proportion on infections at two weeks and 6 weeks of follow-up.(two weeks and six weeks)
- The number of patients recommended to undergo further procedural intervention because of the infection.(12 MONTHS)