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In-office Repair of Chronic Tympanic Membrane Perforations
Sponsor: D. Bradley Welling, MD, PhD
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-06-15
Completion Date
2026-12-30
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
Fibroblast Growth Factor 2
Randomized double-blinded placebo-controlled treatment of 20 patients with chronic (\>6 month), dry tympanic membrane perforations will be repaired with a gelatin sponge soaked with FGF2 or saline in a 3:1 ratio, then covered with a fibrin glue. Up to four applications will be administered at 3 week intervals or until complete healing is observed.
Saline control
Randomized double-blinded placebo-controlled treatment of patients with chronic (\>6 month), dry tympanic membrane perforations will be repaired with a gelatin sponge soaked with saline, then covered with a fibrin glue. Up to four applications will be administered at 3 week intervals or until complete healing is observed.
Locations (1)
Massachusetts Eye and Ear
Boston, Massachusetts, United States