Regenerative treatment for tympanic membrane perforatio
- Conditions
- Perforation of tympanic membrane
- Registration Number
- JPRN-UMIN000006585
- Lead Sponsor
- The Foundation for Biomedical Research and Innovation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
1. TMP due to burn 2. Postoperatively re-perforated TM or patients who underwent surgeries in the inner, middle, or outer ear 3. Poor development of the mastoid pneumatization(MC0 or MC1) defined by the Japan Otological Society 4. Unable to see the whole edge of TMP due to narrow external auditory canal 5. Active infection or inflammation in the inner or middle ear 6. Uncontrolled diabetes mellitus or autoimmune diseases 7. Patients treated with immunosuppressive or anticancer drugs 8. Allergy to drugs (lidocaine, Trafermin/Fibrast, fibrin glue(Bolheal, Beriplast)) or gelatin sponge(Spongel) 9. Requirement for antiplatelet or anticoagulant drugs 10. Females who are pregnant or desire childbearing 11. Patients judged as being inappropriate for this trial by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Closure of tympanic membrane perforation 3 months after the treatment
- Secondary Outcome Measures
Name Time Method 1)Efficacy Improvement of hearing level 3 months after the treatment 2)Safety Adverse events