Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- SSI rate
研究概览
简要总结
Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in spinal fusion surgery. The powder will be locally administered into to the wound cavity before wound closure.
Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical site infections
详细描述
Vancomycin is being widely used as an antibiotic agent for intravenous and topical use. The surgical application of vancomycin powder in Austria is limited as there is no powder with marketing authorization for intraoperative, intrawound usage. Previous reports widely document the application of vancomycin powder for solution for infusion. The powder is not soluted, but instead directly spread throughout the wound surface. Limited data is available for spinal fusion surgery, mostly retrospective studies. Results were promising, but the low evidence level does not allow for a conclusion regarding routine usage. Additional randomized, controlled trials are necessary to further investigate this matter.
This trial aims to investigate Vancomycin powder "Xellia" 1000mg, which has a Marketing authorization, in an off-label usage (intrawound, intraoperatively) in spinal fusion surgery. The investigational medicinal product will be used unmodified.
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
- 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
- •Planned TLIF (transforaminal lumbar interbody fusion) or PLIF (posterolateral lumbar interbody fusion) surgery
- •TLIF/PLIF fusion length of one or two motion-segments OR
- •One motion-segment TLIF/PLIF in conjunction with one motion-segment decompression surgery or microscopic disc surgery (microdiscectomy)
- •Fusions within L1 (first lumbar vertebra) through S1 (sacrum)
- •Age of 18-years or older
- •Signed informed consent
排除标准
- •Preoperative inflammatory or infectious state (C-reactive protein levels above 10mg/l)
- •Allergic to vancomycin, teicoplanin or penicillin
- •Preexisting auto-immune disease with an impaired immune system
- •Current post-traumatic vertebral injury (e.g. vertebral split fracture)
- •Preexisting Renal impairment
- •Preexisting cochlea damage
- •Pregnancy
研究组 & 干预措施
Vancomycin Group
Vancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged
干预措施: Vancomycin (Drug)
结局指标
主要结局
SSI rate
时间窗: 1 year
Rate of superficial and deep surgical site infections (according to CDC criteria)
次要结局
- Revision rate(1 year)
- C-reactive protein(7 days)
研究者
Lukas Panzenboeck
Dr. Lukas Panzenboeck
Orthopedic Hospital Vienna Speising