NCT01559506已完成不适用
ABS to Reduce Contamination in Spine Surgery
Nimbic Systems, LLC2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- CFU Density
研究概览
简要总结
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures
详细描述
The ABS is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Adult patients undergoing lumbar and cervical laminectomy with instrumentation.
排除标准
- •Active infection
- •Prior prosthesis infection
结局指标
主要结局
CFU Density
时间窗: Surgical case CFU density will be determined at up to 1 month from completion of surgical cases
Colony-forming unit density at incision site (CFU/m3)
次要结局
未报告次要终点
研究者
研究点 (2)
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