NCT03883022招募中不适用
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Bony fusion status
研究概览
简要总结
Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have instrumented spine fusion surgery due to failed conservative treatment (bed rest, medication, rehabilitation programs) for 3 to 6 months
- •Patients who are willing to sign the surgical permit after the surgeon explains all surgical procedures along with the surgical risks
- •Patients who fully understand the surgical procedures as well as the surgical risks and are willing to sign the surgical permit and the inform consent
- •Patients who agree one more blood withdrawal after operation
排除标准
- •Patients who agree to accept the spine surgery but do not agree to sign the inform consent
- •Patients who have allergic reaction to vancomycin
研究组 & 干预措施
Vancomycin (V Group)
Experimental
干预措施: with U-VANCO (vancomycin hydrochloride) (Drug)
Without Vancomycin (NV Group)
Active Comparator
干预措施: without U-VANCO (vancomycin hydrochloride) (Drug)
结局指标
主要结局
Bony fusion status
时间窗: Post-operative 1 year
The bony fusion status (Lenke criteria)
Functional outcomes
时间窗: Post-operative 1 year
Functional outcomes, oswestry disability index (ODI)
次要结局
- Vancomycin concentration(Post-operative days 3)
研究者
研究点 (1)
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