Regenerative Treatment for Tympanic Membrane Perforation

Objective: To establish a tissue engineering therapy for the treatment of large tympanic membrane perforation (TMP) without the need for conventional surgical therapy. Study Design: Randomized control trial. Setting: General hospital. Patients and Methods: A total of 63 chronic TMPs were randomly selected from outpatients. Intervention: Of the total 63 chronic TMPs, 53 were randomly assigned to the basic fibroblast growth factor (b-FGF) group and the remaining 10 were randomly assigned to the control group. Materials used for the TM repair were gelatin sponge and fibrin glue with/without b-FGF. After creating a mechanical disruption of the edge of the TMP, a gelatin sponge was immersed in b-FGF or saline (for the control group) and placed over the perforation. Fibrin glue was dripped over the sponge as a sealant. Main Outcome Measures: The effectiveness of this therapy was evaluated by closure rates, hearing level, and sequelae 3 weeks after treatment. The treatment was repeated up to 4 times for cases in which complete closure of the TMP was not achieved after 1 round of treatment. Results: Complete closure of the TMP was achieved in more than 98.1% (52/53) of the patients in the b-FGF group and 10% (1/10) of the patients in the control group. The average hearing level of all patients with successful TM repair was improved. Serious sequelae were not observed in any patient. Conclusion: This study demonstrates that a combination of gelatin sponge, b-FGF, and fibrin glue enables the regeneration of the TM without conventional operative procedures. This innovative regenerative therapy is an easy, safe, cost-effective, and minimally invasive outpatient treatment.