Regenerative Treatment for The Tympanic Membrane Perforation with Cholesteatoma, Tumor, and Sever Calcification

Shin-ichi Kanemaru1,2
1 Department of Otolaryngology–Head and Neck Surgery,bMedical Research Institute, Kitano Hospital, Osaka, Japan
2 Translational Research Informatics Center, The Fundation for Biomedical Research and Innovation, Kobe, Japan

Introduction: We developed a new regenerative treatment for Tympanic membrane (TM) perforations without the need for conventional surgical therapy. In this treatment, we applied to patients with middle ear diseases by using an endoscope.

Methods:
Study Design: Randomized control trial.
Setting: General hospital.
Patients: Fifty seven patients (Age:9-89,M=26,F=31) were selected from patients with/without TM perforation. There were patients with 37 cholesteatomas, 5 tumors and 15 severe calcifications of TM.
Intervention: Materials used for the TM repair were a gelatin sponge with b-FGF and fibrin glue. After removal of lesions through TM perforation, gelatin sponge impregnated with b-FGF was then trimmed to fit the size of the tympanic membrane perforation and placed between the tympanic cavity and the external auditory canal. Fibrin glue was dripped over the sponge. After three weeks, the wound crust is removed from the upper surface of the tympanic membrane to check for regeneration. The effectiveness of this therapy was evaluated finally 6 months after the treatment. The treatment of TM repair was repeated up to 4 times for cases in which complete closure of the TM perforation was not achieved in one treatment cycle.

Discussion:
Results: Complete closure of the TM perforation was achieved in 89% (n=51/57). The average hearing levels of all patients with successful TM repair were improved or maintained. No serious sequelae were observed in any patient.
Conclusions: This new regenerative therapy is useful for the patients with not only simple TM perforation but also above diseases without conventional operative procedures.