Regenerative treatment for tympanic membrane perforation using gelatin sponge with basic fibroblast growth factor
| Autor: | Shin-ichi Kanemaru, Kaoru Omae, Eiji Nakatani, Atsuhiko Kawamoto, Yasushi Naito, Masanori Fukushima, Tsutomu Nishimura, Risa Tona, Hideaki Kaneda |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Tympanic Membrane medicine.medical_treatment Basic fibroblast growth factor Perforation (oil well) Fibrin Tissue Adhesive Myringotomy Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine medicine Humans Regeneration 030223 otorhinolaryngology Fibrin glue Aged Tympanic Membrane Perforation business.industry Cholesteatoma General Medicine Middle Aged medicine.disease Gelatin Sponge Absorbable Surgery Clinical trial Treatment Outcome Otitis Otorhinolaryngology chemistry 030220 oncology & carcinogenesis Female Fibroblast Growth Factor 2 Tissue Adhesives medicine.symptom business |
| Zdroj: | Auris Nasus Larynx. 44:664-671 |
| ISSN: | 0385-8146 |
| DOI: | 10.1016/j.anl.2016.12.005 |
| Popis: | Objective The objective of this study was to evaluate safety and efficacy of regenerative treatment using gelatin sponge with basic fibroblast growth factor (bFGF) in patients with tympanic membrane perforation (TMP). Methods The current study was a prospective, multicenter, open-label, single-arm, and exploratory clinical trial to evaluate the safety and efficacy of the TM regeneration procedure (TMRP). Myringotomy was used to mechanically disrupt the edge of the TMP, and a gelatin sponge immersed in bFGF was then placed over the perforation. Fibrin glue was dripped over the sponge as a sealant. TMP closure was examined 4 weeks later and, if insufficient, TMRP was repeated a maximum of three more times. TMP closure and hearing improvement 12 weeks after the final TMRP as well as safety were evaluated. Results Of the 11 patients with TMP who participated in this study, one who fulfilled the exclusion criteria and did not undergo TMRP and one with cholesteatoma were excluded from the efficacy analysis. TMP closure and hearing improvement 12 weeks after the final TMRP were achieved in eight out of nine patients (88.9%). Mean bone conduction threshold significantly improved 12 weeks after the TMRP compared with baseline (35.7 ± 20.3 vs 29.4 ± 21.0 dB, P = 0.015). Six out of ten patients receiving TMRP experienced temporary adverse events: appendicitis (serious, severe), otorrhea (mild), otitis media (mild), and sudden hearing loss (mild). However, none were related to the protocol treatment. Conclusion TMP closure and hearing improvement were frequently confirmed following the TMRPs which were safely performed. These favorable outcomes were accompanied with significant improvement of the bone conduction threshold. These promising outcomes would encourage a large-scaled, randomized and pivotal clinical trial in the future. This trial is registered at http://www.umin.ac.jp/ctr/index.htm (identifier: UMIN000006585). |
| Databáze: | OpenAIRE |
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