Perforation of tympanic membrane
Conditions
Interventions
Tissue engineering therapy for the treatment of tympanic membrane perforation
Sponsors
The Foundation for Biomedical Research and Innovation
Medical Research Institute, Kitano Hospital Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic otitis media with TMP OR Old traumatic TMP, OR Residual TMP following surgical treatments, OR TMP after the insertion of a ventilation tube in patients with otitis media with effusion 2. On microscope, perfect dry TMP and no active inflammation in the inner, middle, or outer ear; no invasion of epitherium into middle ear vaity and no cholesteatoma 3. Based on temporal bone CT, a. Well pneumatized mastoid (MC2 or MC3) defined by the Japan Otological Society b. Absence of abnormal soft tissue mass c. Normal ossicles 4. Hearing improvement upon patch test 5. Signed written informed consent to participate in the trial
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure of tympanic membrane perforation 3 months after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Efficacy Improvement of hearing level 3 months after the treatment 2)Safety Adverse events | — |
Countries
Japan
Contacts
Public ContactShin-ichi Kanemaru, M.D., Ph.D.
Medical Research Institute, Kitano Hospital Department of Otolaryngology–Head and Neck Surgery
Outcome results
None listed