Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Brief description of study

The purpose of this study is to determine if a protein called fibroblast growth factor-2 (FGF-2) can be safely put on the eardrum and help in the healing of perforations in the tympanic membrane (holes in the eardrum) that are difficult to heal. FGF-2 is considered an investigational drug because the U.S. Food and Drug Administration (FDA) has not approved FGF-2 for treating tympanic membrane perforations.This means that we can only use FGF-2 in research studies. This research study will compare FGF-2 to a sterile solution. The sterile solution looks like FGF-2 when applied, but does not have a medical effect. This is known as a placebo. During this study, you may get a sterile solution instead of FGF-2. Research studies use a placebo (inactive) sterile solution to see if the results are due to the study drug (FGF-2) or due to other reasons. The FGF-2 (or sterile solution) are applied non-surgically.

Clinical Study Identifier: s21-00672

ClinicalTrials.gov Identifier: NCT04960384

Principal Investigator: David R Friedmann.

Other Investigators: J. Thomas Roland Jr., Sean O'Leary McMenomey, Daniel Jethanamest, Erin Byrd.

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