NCT03050203已完成不适用
Surgical Field Custom Pack's Efficacy on Soft Tissue Dissecting Time Reduction, on Relative Risks and Materials Wasted, in Patients Undergoing Spine Surgery: Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Soft Tissue Dissecting Time
研究概览
简要总结
Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Degenerative spinal disease from 2 to 4 levels,
- •Oncologic spine disease with only decompression and stabilization.
排除标准
- •Revision surgeries,
- •Minimally invasive interventions,
- •Interventions that provide a dual access, and
- •Patients who refuse consent to experimentation.
研究组 & 干预措施
custom pack
Experimental
干预措施: custom pack (Other)
standard care
Active Comparator
干预措施: standard care (Other)
结局指标
主要结局
Soft Tissue Dissecting Time
时间窗: up to the first day post intervention
minutes from the start of the dissection to complete bone cleaning
次要结局
- Postoperative Complications(up to 2 weeks)
- Numbers of Materials Wasted(up to the first day post intervention)
- Surgery Time(up to the first day post intervention)
- Blood Loss(up to 2 weeks)
- Pain (Score on the "Numeric Rating Scale")(up to the first 3 days post intervention)
- Length of Stay(up to 2 weeks)
研究者
研究点 (2)
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