Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intra-articular vancomycin concentration
研究概览
简要总结
The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 80
- •Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis
排除标准
- •Diminished mental capacity
- •Vancomycin allergy
- •Chronic kidney disease stage III and stage IV
研究组 & 干预措施
Intrawound Administration of Vancomycin
After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 20ml of normal saline was injected directly into the joint.
干预措施: Intrawound administration of vancomycin after closure of the arthrotomy (Procedure)
Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)
After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint.
干预措施: Intrawound administration of vancomycin after closure of the arthrotomy (Procedure)
结局指标
主要结局
Intra-articular vancomycin concentration
时间窗: 2 hours, 8 hours and 24 hours postoperatively
Serum vancomycin concentration
时间窗: 2 hours, 8 hours and 24 hours postoperatively
Renal function
时间窗: Postoperative Day 1 and Day 3
blood urea nitrogen (BUN), creatinine (Cr), GFR
Blood loss
时间窗: Postoperative Day 3
次要结局
未报告次要终点
研究者
Xiang Shuai, MD
Principal Investigator
The Affiliated Hospital of Qingdao University