In-office Repair of Chronic Tympanic Membrane Perforations

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Tympanic Membrane Perforation

In brief

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.

Key facts

Study ID

NCT06448039

Run by

D. Bradley Welling, MD, PhD

People needed

20

Starts

2024-06-15

Expected to finish

2026-12-30

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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