Monitoring of the Bone Free Flaps With Microdialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
研究概览
简要总结
Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone free flaps, and they all describe the position of the catheter in the surrounding soft tissue muscle which is not the accurate reflect of bone vascularisation. The aim of this study is to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.
详细描述
Failure rate of facial reconstructive surgery with bone free flaps varies between 11 and 25%. In case of buried bone free flaps, the follow up is even more difficult. Monitoring methods, such as the implantable Doppler system, laser Doppler flowmetry and microdialysis have been developped in the last 15 years. Ferguson et al. show a false positive rate of 31% with implantable doppler monitoring of buried flaps.
The purpose of this study is to to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 person
- •signed informed consent
- •head and neck reconstruction with iliac crest or fibula free flap
- •patient covered by national health insurance
排除标准
- •minor person
- •head and neck reconstruction with other types of free flaps than crest or fibula free flap
- •pregnant or breastfeeding women
结局指标
主要结局
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
时间窗: every 3 hours at days 2, 3 , 4 and 5 after surgery
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
次要结局
- Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia(every 3 hours at days 2, 3 , 4 and 5 after surgery)
- Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia(every 3 hours at days 2, 3 , 4 and 5 after surgery)
- Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia(every 3 hours at days 2, 3 , 4 and 5 after surgery)
- Change from Baseline of metabolites rate in patients with free flap ischemia(every 3 hours at days 2, 3 , 4 and 5 after surgery)