Trail of facial nerve decompression using basic fibroblast growth factor
- Conditions
- Bell's palsy, Ramsay Hunt syndrome, or facial paralysis caused by temporal bone fracture
- Registration Number
- JPRN-jRCTs061220098
- Lead Sponsor
- Hato Naohito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 96
1. 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
3. 16 years or more
4. having severe or complete facial paralysis corresponding to House-Brackmann (H-B) grade 5 or 6, or
Yanagihara score 10 or less
5. having a degree of denervation exceeding 95% as determined through electroneuronography
6. provided informed consent by the individual or surrogate.
1. having a history of malignancies or currently undergoing treatment
2. being pregnant or may be pregnant or lactating mothers
3. patients with chronic kidney failure or liver failure
4. patients with a compromised immune system
5. do not wish to undergo facial nerve decompression
6. having a history of allergy to gelatin or trafermin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. good recovery rates 1 year after onset. <br>Good recovery rates are grade II or less by the House-Brackmann method or 32 points or more by the Yanagihara method.
- Secondary Outcome Measures
Name Time Method 1. good recovery rates 6 months after onset<br>Good recovery rates are grade II or less by the House-Brackmann method or 32 points or more by the Yanagihara method.<br>2. FaCE scale 6 months after onset and 1 year after onset<br>3. incidence of sequelae 1 year after onset<br>4. the difference of the pure-tone audiometric thresholds between pre-operation and 1 year after onset.