In-office Repair of Chronic Tympanic Membrane Perforations

Summary

The goal of this clinical trial is to compare the application of fibroblast growth factor 2 (FGF2) with normal saline for the healing of chronic tympanic membrane (TM) perforations. This is an extension of a prior study. The main question it aims to answer is: Will modifications to our prior surgical trial provide higher success rates in obtaining complete closure of chronic tympanic membrane perforations? Twenty participants will be randomized in a controlled study to FGF2 or saline in a 3:1 ratio and the total tympanic membrane closure compared.

Timeline

Start

2024-06-15

Primary completion

2026-05-13

Completion

2026-12-30

Publications

• Background Santos F, Shu E, Lee DJ, Jung DH, Quesnel AM, Stankovic KM, Abdul-Aziz DE, Bay CP, Quinkert A, Welling DB. Topical fibroblast growth factor-2 for treatment of chronic tympanic membrane perforations. Laryngoscope Investig Otolaryngol. 2020 May 14;5(4):657-664. doi: 10.1002/lio2.395. eCollection 2020 Aug.
• Background Hakuba N, Iwanaga M, Tanaka S, Hiratsuka Y, Kumabe Y, Konishi M, Okanoue Y, Hiwatashi N, Wada T. Basic fibroblast growth factor combined with atelocollagen for closing chronic tympanic membrane perforations in 87 patients. Otol Neurotol. 2010 Jan;31(1):118-21. doi: 10.1097/MAO.0b013e3181c34f01.
• Background Kanemaru S, Umeda H, Kitani Y, Nakamura T, Hirano S, Ito J. Regenerative treatment for tympanic membrane perforation. Otol Neurotol. 2011 Oct;32(8):1218-23. doi: 10.1097/MAO.0b013e31822e0e53.

Drugs

Indications