NCT01173133Unknown不适用
Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
Spectros Corporation1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Flap Failure and Compromise by Tissue Saturation Values (Efficacy)
研究概览
简要总结
The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.
详细描述
The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under surgical breast reconstruction
- •Informed consent
排除标准
- •Failure to give consent
结局指标
主要结局
Flap Failure and Compromise by Tissue Saturation Values (Efficacy)
时间窗: 72 hours
次要结局
- Oximetric Diagnosis compared to Clinical Diagnosis, Doppler(72 hours)
- Device Safety Measures (safety)(72 hours)
研究者
研究点 (1)
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