Could a gel patch fix a hole in your ear drum?
NCT ID NCT04960384
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether a gel containing fibroblast growth factor-2 (FGF-2) can close long-standing holes in the ear drum. 52 adults with dry ear drum perforations lasting at least 6 months were randomly assigned to receive either the FGF-2 gel or a placebo, applied up to three times. The main goal was to see if the hole closed, measured by ear exams and photos.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FGF-2 (fibroblast growth factor-2) applied on a gelatin sponge with fibrin glue
- What this could lead to
- If it works, this could provide a simple, non-surgical way to close chronic ear drum holes, potentially improving hearing and reducing infection risk.
- What could go wrong
- This is a small phase 2 trial with only 52 participants, so results may not apply to everyone. The treatment may not close the hole, and risks like infection or incomplete healing are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
52 people
The number who actually took part.
- Started
-
May 2022
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years and older * Dry tympanic membrane perforation of at least 6 months duration * Any person of child-bearing potential, must have a negative beta-HCG test and must agree to use an adequate form of birth control throughout the clinical trial. Exclusion Criteria: * Active otitis media or chronic otorrhea from the middle ear * Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents, or chemotherapy * Subjects who, at study entry, are taking systemic antibiotics * Subjects who are immunosuppressed * Subjects experiencing bacterial or viral infection or who may otherwise be febrile or may be with inflammation. * Life expectancy of less than 1 year * Active alcohol or drug abuse within 6 months prior to study entry * Significant medical condition that could prevent full participation in the procedures required for the study * Known or suspected allergies to any components used in the study, i.e. porcine collagen * Subjects who have cholesteatoma mass, or endothelium invasion in the tympanic cavity * Subjects whose total perforation cannot be seen by an endoscope * Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher) * Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility * Subjects who have undergone prior myringoplasty or tympanoplasty * Subjects whose TMP is a result of thermal burn, or radiation therapy. * Subjects who have abnormalities in the auditory ossicles or their linkages * Subjects having moderate to severe dementia such as Alzheimer's disease or senile dementia * Subjects whose hearing ability does not improve to bone-conduction hearing on a hearing acuity test using the tentative closure of perforation with a wet cotton ball. * Subject having residual TM with abnormal form or abnormal shape anatomically * Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
NYU Langone Health
New York, New York, 10016, United States
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Other studies related to the condition(s) this trial covers.
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