跳至主要内容
临床试验/NCT07282782
NCT07282782招募中4 期

A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月10日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
30
试验地点
2
主要终点
Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood

研究概览

简要总结

Periprosthetic joint infection (PJI) is a national health crisis and leads to very poor outcomes for patients undergoing elective joint replacement. Within the realm of elective total knee arthroplasty (TKA), various methods of infection prophylaxis are in place. These include sterile precautions, would/tissue handling, and antibiotic prophylaxis. With respect to the latter, various approaches have been utilized including intravenous and intraosseous administration of vancomycin, preoperatively. Intraosseous administration does require another wound and a specific device to administer. The investigators proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost.

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

  • Any patient over the age of 18 years of age receiving treatment at UC San Diego Health
  • Undergoing primary unilateral TKA
  • Ability to provide consent

排除标准

  • previous surgery on the knee (with the exception of arthroscopy)
  • BMI > 35
  • contraindication to receiving vancomycin, cefepime or cefazolin (ie, allergy, etc)
  • diabetics with A1c>7.5% (unless controlled fructosamine)
  • immunocompromised or immunosuppressed patients (HIV, Hepatitis C, end stage renal disease (ESRD), post transplant, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating meducations)
  • no history of active infections
  • no history of chronic kidney disease

研究组 & 干预措施

Intraosseous (IO) Vancomycin

Experimental

500mg dose Vancomycin (in 100mL saline)

干预措施: Vancomycin (Drug)

Intraarticular (IA) Vancomycin

Experimental

500mg dose Vancomycin (in 30mL saline)

干预措施: Vancomycin (Drug)

结局指标

主要结局

Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood

时间窗: Intraoperative

次要结局

未报告次要终点

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 (2)

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