At a glance
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Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
In Brief
A Phase 2 clinical trial evaluating FGF-2 and Placebo for Tympanic Membrane Perforation. Completed, enrolled 57 participants across 2 sites.
Detailed Summary
A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.
Study Details
Timeline
Interventions
The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery.
Placebo comparator using a sterile saline solution.