jRCTs061220098招募中不适用
Evaluation of the regeneration facilitating effects of facial nerve decompression using basic fibroblast growth factor for severe facial paralysis
未提供0 个研究点目标入组 96 人开始时间: 2023年4月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 主要终点
- good recovery rates
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 16age old over 至 No limit（—）
- 性别
- All
入选标准
- •patients with Bell's palsy, Ramsay Hunt Syndrome, or facial paralysis caused by temporal bone fracture
- •2.cases within 4 months from 2 weeks after paralysis onset
- •16 years or more
- •having severe or complete facial paralysis corresponding to House-Brackmann (H-B) grade 5 or 6, or
- •Yanagihara score 10 or less
- •having a degree of denervation exceeding 95% as determined through electroneuronography
- •provided informed consent by the individual or surrogate.
排除标准
- •having a history of malignancies or currently undergoing treatment
- •being pregnant or may be pregnant or lactating mothers
- •patients with chronic kidney failure or liver failure
- •patients with a compromised immune system
- •do not wish to undergo facial nerve decompression
- •having a history of allergy to gelatin or trafermin
结局指标
主要结局
good recovery rates
时间窗: 1 year after onset
Good recovery rates are grade II or less by the House-Brackmann method or 32 points or more by the Yanagihara method.
次要结局
- good recovery rates 6 months after onset(6 months after onset)
研究者
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