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临床试验/NCT07633418
NCT07633418尚未招募4 期

Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月1日最近更新:

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Ball, MD

Clinical Professor

University of California, San Diego

研究点 (1)

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