Intraosseous Vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systemic Sample Vancomycin Tissue Concentration - Start of Case
研究概览
简要总结
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).
Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.
Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
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)
盲法说明
single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravenous Vancomycin
Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL normal saline (NS))
干预措施: Intravenous Vancomycin (Drug)
Intraosseous Vancomycin
IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group.
IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
IO Injection will take place into the medial malleolus.
干预措施: Intraosseous Vancomycin Injection (Drug)
结局指标
主要结局
Systemic Sample Vancomycin Tissue Concentration - Start of Case
时间窗: perioperatively
Capsule or Synovium Sample Vancomycin Tissue Concentration
时间窗: immediately after the procedure
Talar Bone Sample Vancomycin Tissue Concentration
时间窗: immediately after the procedure
Systemic Sample Vancomycin Tissue Concentration - End of Case
时间窗: perioperatively
Distal Tibia Sample Vancomycin Tissue Concentration
时间窗: immediately after the procedure
次要结局
- 90 day post-operative wound complication and infection rates(90 days after the procedure)
研究者
Jason S. Ahuero
Orthopedic Surgeon
The Methodist Hospital Research Institute