Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of Postoperative Infections
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital. The main questions it aims to answer are:
Does IO administration of vancomycin and cefazolin protect against perioperative exposure risks? Is there a difference in post-operative complication rates between IV and IO administration of these drugs?
Participants will be randomized to receive either the standard of care IV administration of Vancomycin and Cefazolin, or the IO administration of Vancomycin and Cefazolin.
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 (Participant)
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
- •Patient is scheduled to undergo an elective primary total knee arthroplasty.
- •Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
- •Patient is 18 years or older.
排除标准
- •Contraindication to receiving vancomycin or cefazolin.
- •Body mass index (BMI) >
- •Uncontrolled Diabetes (defined as A1c > 7.5%).
- •Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure.
- •Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site.
- •Refusal to participate
- •Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.
研究组 & 干预措施
Intraosseous Administration of Vancomycin and Cefazolin
Intraosseous vancomycin plus cefazolin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision and after the tourniquet has been inflated. The injection will take place into the tibial tubercle, which is a known safe IO injection site. The IO injection will include 500mg of vancomycin and a 1g dose of cefazolin, previously used in prior IO studies of cefazolin.
干预措施: IO Administration of Cefazolin (Drug)
Intraosseous Administration of Vancomycin and Cefazolin
Intraosseous vancomycin plus cefazolin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision and after the tourniquet has been inflated. The injection will take place into the tibial tubercle, which is a known safe IO injection site. The IO injection will include 500mg of vancomycin and a 1g dose of cefazolin, previously used in prior IO studies of cefazolin.
干预措施: IO Administration of Vancomycin (Drug)
Standard IV Administration of Vancomycin and Cefazolin
Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics cefazolin will be started in the pre-operative period approximately 1 hour prior to incision. The cefazolin dose is generally 2g if patient is under 120kg, and 3g is the patient is above 120kg in line with guidelines. Vancomycin IV administration will be dosing will be weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS.
干预措施: IV Administration of Cefazolin (Drug)
Standard IV Administration of Vancomycin and Cefazolin
Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics cefazolin will be started in the pre-operative period approximately 1 hour prior to incision. The cefazolin dose is generally 2g if patient is under 120kg, and 3g is the patient is above 120kg in line with guidelines. Vancomycin IV administration will be dosing will be weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS.
干预措施: IV Administration of Vancomycin (Drug)
结局指标
主要结局
Rate of Postoperative Infections
时间窗: 30 days postop and 90 days postop
Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any infections.
次要结局
- Postoperative Wound Complications(30 days postop and 90 days postop)
研究者
Brian Parsley
Physician
The Methodist Hospital Research Institute