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Regenerative treatment for tympanic membrane perforation using gelatin sponge with basic fibroblast growth factor
Kaoru Omae1, Shin-Ichi Kanemaru2, Eiji Nakatani1
1Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan.
Auris, Nasus, Larynx
|January 26, 2017
Summary
Regenerative treatment using gelatin sponge with basic fibroblast growth factor (bFGF) effectively closed tympanic membrane perforations (TMP) and improved hearing. The TM regeneration procedure (TMRP) showed promising safety and efficacy, warranting further large-scale trials.
Area of Science:
- Otolaryngology
- Regenerative Medicine
- Biomaterials Science
Background:
- Tympanic membrane perforation (TMP) can lead to hearing loss and requires effective treatment.
- Current treatment options for TMP have limitations.
- Regenerative approaches offer potential for improved outcomes.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel regenerative treatment for TMP.
- To assess the use of gelatin sponge with basic fibroblast growth factor (bFGF) for TM repair.
Main Methods:
- A prospective, multicenter, open-label, single-arm clinical trial was conducted.
- The TM regeneration procedure (TMRP) involved mechanical disruption of the perforation edge, application of bFGF-soaked gelatin sponge, and fibrin glue sealant.
- TMP closure and hearing improvement were assessed 4 and 12 weeks post-procedure.
Main Results:
- The TMRP achieved an 88.9% closure rate in nine patients.
- Significant improvement in bone conduction threshold was observed 12 weeks after TMRP (P=0.015).
- Temporary adverse events occurred but were unrelated to the treatment protocol.
Conclusions:
- The TMRP using gelatin sponge and bFGF is a safe and effective regenerative treatment for TMP.
- The procedure resulted in high rates of TM closure and significant hearing improvement.
- These findings support the initiation of larger, randomized clinical trials for this regenerative therapy.
