SuspendedPhase 1/2

In-office Repair of Chronic Tympanic Membrane Perforations

Stopped: Study drug is no longer available from Nobelpharma

United States20 participantsStarted 2024-06-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years of age and older.
✓. Confirmed tympanic membrane perforation for more 6 months or longer.
✓. Confirmed dry perforation.
✓. Confirmed central perforation.
✓. Ability to provide informed consent.

Exclusion criteria

✕. Patient is receiving or has a prior history of radiation treatment.
✕. Prior tympanoplasty with failure.
✕. Currently use of corticosteroids, immunosuppressive agents, or chemotherapy.
✕. Active middle ear infection or inflammation on otoscopic examination

What they're measuring

Complete closure of tympanic membrane perforation

Timeframe: Six months

Tympanometry

Timeframe: Six months

Trial details

NCT IDNCT06448039

SponsorD. Bradley Welling, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-30

View on ClinicalTrials.gov More Chronic Tympanic Membrane Perforation trials