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Evaluation of the regeneration facilitating effects of facial nerve decompression using basic fibroblast growth factor for severe facial paralysis

Trail of facial nerve decompression using basic fibroblast growth factor

Hato Naohito

Ehime University Hospitsl

454 Shitsukawa, Toon, Ehime, Japan

nhato@m.ehime-u.ac.jp

Yamada Hiroyuki

Ehime University Hospitsl

454 Shitsukawa, Toon, Ehime, Japan

+81-89-960-5366

yamada.hiroyuki.mk@ehime-u.ac.jp

Recruiting

Feb. 20, 2023

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

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

Both

Bell's palsy, Ramsay Hunt syndrome, or facial paralysis caused by temporal bone fracture

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 dexamethasone solution is placed around the exposed facial nerve after facial nerve decompression surgery.

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.

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.

+81-89-960-5172

Jan. 31, 2023

No

none