Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Incidence of deep spinal infections
研究概览
简要总结
Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center
- •Ability to understand and sign written informed consent by the patient or legal guardian
排除标准
- •Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment)
- •Receiving ongoing treatment of antibiotics for other infections
- •Sensitivity or allergy to vancomycin or cefazolin
- •Previous spine surgery at the index level within the last 90 days
- •Postoperative radiotherapy of the surgical site required (e.g. for tumor)
- •Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse
- •Undergoing spinal decompression only
- •Trauma patients
- •Pregnancy
研究组 & 干预措施
Intervention group: 500 mg vancomycin
Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis
干预措施: Vancomycin (Drug)
Intervention group: 1 g vancomycin
Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis
干预措施: Vancomycin (Drug)
结局指标
主要结局
Incidence of deep spinal infections
时间窗: One year
According to Center for Disease Control and Prevention (CDC) criteria
次要结局
- Incidence of superficial spinal infections(One year)
- Individual components of the composite primary outcomes(One year)
- Rate of Surgical site infection revisions(30 days)
- Number of adverse events(Up to one week post-surgery)
- Length of hospitalization(From operation date to discharge (up to 4 weeks) or date of death)
- Rate of mortality(One year)
- Rate of post-operative seroma(30 days)
- Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)(Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30)
- Serum vancomycin levels(6 and 12 hours post op and then one test a day until vancomycin levels reach zero)
研究者
Eyal Itshayek
Prof. Eyal Itshayek
Rabin Medical Center