Bell's palsy, Ramsay Hunt syndrome, or facial paralysis caused by temporal bone fracture
Conditions
Interventions
arm A A bFGF-impregnated biodegradable gelatin hydrogel sheet is placed around the exposed facial nerve after facial nerve decompression surgery.
arm B Sterile Compressed Sponge soaked in dexameth
Sponsors
Hato Naohito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. good recovery rates 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. good recovery rates 6 months after onset Good recovery rates are grade II or less by the House-Brackmann method or 32 points or more by the Yanagihara method. 2. FaCE scale 6 months after onset and 1 year after onset 3. incidence of sequelae 1 year after onset 4. the difference of the pure-tone audiometric thresholds between pre-operation and 1 year after onset. | — |
Contacts
Public ContactHiroyuki Yamada
Ehime University Hospitsl
Outcome results
None listed