Effect of intrawound vancomycin in prevention of surgical site infection/periprosthetic joint infection after primary total knee arthroplasty: prospective RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Acute infection rate: Incidence of Surgical Site Infections (SSI) or Periprosthetic Joint Infection (PJI)
研究概览
简要总结
Infection is a dreaded complication of total joint replacement surgery.
Antibiotic protocols vary widely across institutions and countries in the prevention of peri-prosthetic joint infections after total knee replacement surgery.
Several studies in the western literature have shown intra-wound/ intra-articular antibiotic powder to reduce the infection rates after primary total knee arthroplasty. However, there are no randomised control trials on this subject. Most studies are inadequately powered, or retrospective analyses.
Intra-articular vancomycin has been proven to be safe without systemic effects of toxicity.
Primary purpose:
The aim of this study is to evaluate efficacy of Local intra-articular/intra-wound vancomycin powder on infection rates after primary total knee arthroplasty.
Null Hypothesis: There is no difference in infection rates after primary total knee arthroplasty between patients receiving standard intravenous single dose antibiotic (IV Cefuroxime 1.5g) versus those receiving ccefuroxime + intra-articular vancomycin powder before closure of joint.
The primary outcome is to assess acute infection rate at 3 months (Early infections) after primary TKR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients undergoing primary total knee arthroplasty for osteoarthritis of the knee joint.
排除标准
- •Inflammatory arthritis Post-traumatic arthritis Previous knee surgery.
结局指标
主要结局
Acute infection rate: Incidence of Surgical Site Infections (SSI) or Periprosthetic Joint Infection (PJI)
时间窗: Assessment and documentation of surgical site infection (SSI) or Peri-prosthetic Joint Infection (PJI) at 2 weeks, 4 weeks, 3 months, 6 months, 1 year after surgery
次要结局
- Long term Infection rate(1 year)
- Functional outcomes using WOMAC score(3 months, 6 months, 1 year)
- Functional outcome assessed by Oxford Knee Score (OKS)(3 months, 6 months, 1 year)
- Functional outcomes assessment by Patient reported outcome measure (PROM) by Forgotten Joint Score (FJS)(3 months, 6 months, 1 year)
- Quality of Life Indicator (EQ-5D)(3 months, 6 months, 1 year)
- Correlation of patient factors with infection rates(6 months and 1 year)