Tissue Concentrations of Vancomycin Achieved With Bier Block Administration Versus Intravenous Prophylaxis in Upper Extremity Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tissue concentrations of vancomycin
研究概览
简要总结
The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (upper extremity) is more effective at preventing infection than the current standard dose which is given intravenously (IV).
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
- Single (Outcomes Assessor)
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
- •Patients undergoing upper extremity reconstruction by a single surgeon.
- •Surgical cases will include:
- •Trapeziectomy/suspensionplasty.
- •PIPJ/MPJ arthroplasty.
- •Proximal row carpectomy.
- •Distal ulnar resection.
- •Distal radius fracture fixation.
排除标准
- •Inability to adequately cannulate a superficial vein in the upper extremity within 5 minutes of tourniquet inflation.
- •Evidence of subcutaneous extravasation in Bier block group.
- •History of renal dysfunction.
- •Vancomycin allergy.
- •History of lung cancer.
- •Known HIV infection.
- •History of organ transplantation.
研究组 & 干预措施
Systemic Intravenous IV Group
Subjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery.
干预措施: Systemic IV Vancomycin (Drug)
Bier Block Group
Subjects will receive antibiotic Vancomycin from a Bier Block (injected into an arm vein with a tourniquet up to keep antibiotics in the arm). Samples will be collected from bone and tissue that is normally removed during surgery.
干预措施: Bier Block (Procedure)
Bier Block Group
Subjects will receive antibiotic Vancomycin from a Bier Block (injected into an arm vein with a tourniquet up to keep antibiotics in the arm). Samples will be collected from bone and tissue that is normally removed during surgery.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Tissue concentrations of vancomycin
时间窗: Approximately 45-60 minutes after skin incision
Tissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration
次要结局
- Adverse Events(1 year)
研究者
Kevin J. Renfree
Principal Investigator
Mayo Clinic