To establish a tissue engineering therapy for the treatment of large tympanic membrane perforation (TMP) without the need for conventional surgical therapy.
Randomized control trial.
A total of 63 chronic TMPs were randomly selected from outpatients.
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.
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.
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.
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.
*Department of Otolaryngology - Head and Neck Surgery, Medical Research Institute, Kitano Hospital, Osaka; †Department of Otolaryngology - Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto; ‡Department of Otolaryngology, Shizuoka General Hospital, Shizuoka; and §Department of Bioartificial Organs, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan
Address correspondence and reprint requests to Shin-Ichi Kanemaru, M.D., Ph.D., Department of Otolaryngology - Head and Neck Surgery, Medical Research Institute, Kitano Hospital, Osaka, Japan, 2-4-20 Ohgimachi, Kitaku, Osaka, 530-8480, Japan; E-mail: firstname.lastname@example.org
This study was supported by a Health Sciences Research Grant from the Ministry of Health, Labor, and Welfare of Japan and the National Institute of Biomedical Innovation in Japan.
This article was recommended by the Japan Otological Society.