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Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

NCT02307916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-12-08

Study results available
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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.

Conditions

  • Tympanic Membrane Perforation

Interventions

DRUG

FGF-2

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.

OTHER

Placebo

Placebo comparator using a sterile saline solution.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • D. Bradley Welling, MD, PhD

    lead OTHER

Principal Investigators

  • D. B. Welling, M.D., Ph.D · Massachusetts Eye and Ear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-07-31
Completion
2020-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02307916 on ClinicalTrials.gov