Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
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 flaps, and they all described the position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue is not always the reflect of bone vascularisation.
The aim is to study the feasibility of a follow up of microanastomosed bone flaps with microdialysis. To reach this goal, investigators perform a clinical prospective research project untitled MTM project
详细描述
In addition to our classical clinical monitoring, bone microanastomosed flaps for reconstructive facial surgery will be monitored with CMA 70 catheter directly positioned in bone tissue.
The monitoring is recorded during 5 days. Glucose, lactate , pyruvate , glycerol rates will be analysed :
- every hour at day 1,
- every two hours at day 2,
- every three hours at day 3,4 and 5.
Data are managed with Labpilot software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •head and neck reconstruction with iliac crest or fibula free flaps
- •informed consent obtained
排除标准
- •reconstruction with other types of free flaps
研究组 & 干预措施
Microdialysis with CMA 70 catheter
CMA 70 catheter directly positioned in bone tissue
干预措施: CMA 70 catheter directly positioned in bone tissue (Device)
结局指标
主要结局
Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
时间窗: Day 5 after catheter insertion
Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.
次要结局
- Evaluation of "flush-out" period(Day 5 after catheter insertion)
- Compliance of the prescription(Day 5 after catheter insertion)