severe vocal folds scar scar
Conditions
Interventions
A tracheostomy is performed under general anesthesia, followed by a laryngofissure. The bilateral vocal fold scars are excised, and each side is covered with an amniotic membrane (approximately 10 mm
D000650
Sponsors
Shigeru Hirano
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Severe vocal folds scar 2) Diagnosed as severe vocal folds scar more than 12 weeks before 3) 18 years to 75 years, any gender 4) No other vocal lesion or vocal movement disorder 5) No laryngoplasty, collagen or lipid infusion to vocal fold, removal scar, fascialgraft, or administration of bFGF, HGF, steroid, or hyaluronic acid to vocal fold within 24 weeks 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Airway disease caused by burn 2) Taking anticoagulant or antiplatelet drugs 3) Serious uncontrolled concomitant disease 4) Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods 5) Participation to other clinical trial within 12 weeks 6) Judged as inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Normalized Mucosal Wave Amplitude (NMWA) at 24 weeks postoperative 2) Improvement of GRBAS scale from prior to transplantation to 24 weeks postoperative 3) Improvement of VHI-10 score from prior to transplantation to 24 weeks postoperative | — |
Contacts
Public ContactImai Kojiro
Graduate school of Medical Science, Kyoto Prefectural University of Medicine
Outcome results
None listed