EUCTR2014-002096-29-AT进行中（未招募）不适用
Application of Intrawound Vancomycin Powder in Spinal Fusion Surgery to Reduce Postoperative Surgical Site Infections - A Prospective Randomized Controlled Trial
Speising Orthopaedic Hospital Vienna0 个研究点开始时间: 2015年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •Preoperative inflammatory or infectious state (C-reactive protein levels above 5mg/l)
- •Diabetes mellitus type I or II
- •Allergic to vancomycin, teicoplanin or penicillin
- •Preexisting malignant disease
- •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
- •The surgery cannot be undertaken for any other reasons
研究者
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