Multicenter phase III trial of regenerative treatment for chronic tympanic membrane perforation

Shin ichi Kanemaru, Rie Kanai, Koichi Omori, Norio Yamamoto, Takayuki Okano, Ippei Kishimoto, Kaoru Ogawa, Sho Kanzaki, Masato Fujioka, Naoki Oishi, Yasushi Naito, Seiji Kakehata, Hajime Nakamura, Shinobu Yamada, Kaoru Omae, Atsuhiko Kawamoto, Masanori Fukushima

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To evaluate the efficacy and safety of regenerative treatment for tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue. Methods: This was a multicenter, non-randomized, single-arm study conducted at tertiary referral centers. Twenty patients with chronic TMP (age 23–78 years, 6 males, 14 females) were registered from three institutions. All treated patients were included in the safety analysis population. The edges of the TMP were disrupted mechanically by myringotomy and several pieces of gelatin sponge immersed in bFGF were placed and fixed with fibrin glue to cover the perforation. The TMP was examined 4 ± 1 weeks later. The protocol was repeated up to four times until closure was complete. The main outcome measures were closure or a decrease in size of the TMP, hearing improvement, and air–bone gap evaluated 16 weeks after the final regenerative procedure (FRP). Adverse events (AEs) were monitored throughout the study. Results: Total closure of the TMP at 16 weeks was achieved in 15 out of 20 patients (75.0%, 95% confidence interval [CI]: 50.9%–91.3%) and the mean decrease in size was 92.2% (95%CI: 82.9%–100.0%). The ratio of hearing improvement and the air–bone gap at 16 weeks after FRP were 100% (20/20; 95%CI: 83.2%–100%) and 5.3 ± 4.2 dB (p <0.0001), respectively. Thirteen out of 20 patients (65.0%) experienced at least one AE, but no serious AEs occurred. Conclusion: The results indicate that the current regenerative treatment for TMP using gelatin sponge, bFGF, and fibrin glue is safe and effective.

Original languageEnglish
Pages (from-to)1054-1060
Number of pages7
JournalAuris Nasus Larynx
Volume48
Issue number6
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • Basic fibroblast growth factor
  • Fibrin glue
  • Gelatin sponge
  • Multicenter investigator-initiated trial
  • Regenerative treatment
  • Tympanic membrane

ASJC Scopus subject areas

  • Surgery
  • Otorhinolaryngology

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