JPRN-UMIN000006585
Recruiting
Phase 2
Regenerative treatment for tympanic membrane perforation - Regenerative treatment for tympanic membrane perforation
The Foundation for Biomedical Research and Innovation0 sites10 target enrollmentOctober 21, 2011
ConditionsPerforation of tympanic membrane
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Perforation of tympanic membrane
- Sponsor
- The Foundation for Biomedical Research and Innovation
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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