Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a patient over the age of 18 receiving treatment at UC San Diego
- •Is undergoing primary unilateral total knee arthroplasty
- •Is able to provide consent
- •Is candidate for IO administration of Vancomycin
排除标准
- •Has had a previous surgery on the knee of interest (with the exception of arthroscopy)
- •Has a BMI >35
- •Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)
- •Has diabetes with A1c >7.5% (unless with controlled fructosamine)
- •Is immunocompromised/immunosuppressed (i.e. due to HIV, hepatitis C, end-stage renal disease, post-transplant status, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating medications)
- •Has a history of active infection
- •Inability to provide consent
- •Pregnant women
研究者
Scott Ball, MD
Clinical Professor
University of California, San Diego
