Regional Prophylactic Vancomycin in Revision Total Knee Replacement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Mean Concentration of Vancomycin in Subcutaneous Fat
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 (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.
详细描述
Patients were assigned to one of two groups by chance (like a coin toss):
- GROUP 1 - Received 500mg of vancomycin into the tibia (shin) bone of the leg being operated on.
- GROUP 2 - Received 1g of vancomycin, which is the amount normally given to patients.
For both groups, the revision knee replacement will then be carried out as normal.
OTHER ANTIBIOTICS All patients received cefazolin IV (an antibiotic used to prevent infection) prior to the beginning of surgery to ensure effective preventive antibiotics. The patient will also received 3 postoperative doses of cefazolin over a 24-hour period (4 doses in total). This is standard of care for all total knee replacement surgeries.
TISSUE SAMPLES
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
- 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
- •Revision total knee arthroplasty
- •Informed consent given
排除标准
- •Current treatment with IV Vancomycin within the preceding 7 days
- •Previous hypersensitivity to vancomycin
- •Significant cardiac or respiratory abnormality
- •Contraindications to using the intraosseous vascular access system (EZ-IO)
研究组 & 干预措施
Vancomycin 500mg intraosseous
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
干预措施: Vancomycin (Drug)
Vancomycin 1g IV
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Mean Concentration of Vancomycin in Subcutaneous Fat
时间窗: Baseline to 24 hours
During the procedure, subcutaneous fat samples (approximately 0.5 cm\^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.
Mean Concentration of Vancomycin in Bone Samples
时间窗: baseline to 24 hours
During the procedure, bone samples (approximately 0.5 cm\^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.
次要结局
未报告次要终点