Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
研究概览
简要总结
This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.
详细描述
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.
The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated nerve transections of the digits, forearm, wrist, and palm will be included.
- •Class III nerve injury (Sunderland's 4th or 5th degree injury)
- •Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
- •Pregnant and breastfeeding women cannot participate because of possible unknown and unpredictable risks to the unborn child.
- •Injuries beyond 24 hours will be excluded
排除标准
- 未提供
研究组 & 干预措施
Nerve injury to palm and fingers
Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited
干预措施: Polyethylene Glycols (Drug)
结局指标
主要结局
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
时间窗: 12 months
Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure
次要结局
未报告次要终点