NCT07384689招募中不适用
MiAMII Study - Microdialysis Acquired SaMpling of Ischemia, Inflammation and Antibiotics Locally in Amputation Stump: A Comparative Study in Diabetic and Non-Diabetic Patients Undergoing Non-Traumatic Transfemoral Amputation
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ischemia
研究概览
简要总结
The microenvironment of the amputation stump in patients undergoing non-traumatic transfemoral amputation will be investigated with a combination of microdialysis and tissue sampling.
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
- 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
- •18 years or older
- •Cognitive ability to provide informed consent
- •Scheduled for transfemoral amputation at Aarhus University Hospital
排除标准
- •Non-vascular indication of amputation
- •Already amputated on the contralateral leg
- •Insufficient flap perfusion
- •Allergic or sensitivity to silver or acrylic adhesives
研究组 & 干预措施
ciNPWT
Active Comparator
干预措施: ciNPWT (Device)
SSD
Active Comparator
干预措施: SSD (Other)
结局指标
主要结局
Ischemia
时间窗: Within 72 hours postoperatively
Concentration of ischemic metabolites: Glucose, Lactate, Pyruvate and Glycerol
次要结局
未报告次要终点
研究者
Rehne Lessmann Hansen
Senior registrar at the department of Orthopaedic Surgery, Amputation and infections unit, PhD
Aarhus University Hospital
研究点 (1)
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