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In-office Repair of Chronic Tympanic Membrane Perforations

NCT06448039 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • Chronic Tympanic Membrane Perforation

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Nobelpharma

    collaborator INDUSTRY

  • D. Bradley Welling, MD, PhD

    lead OTHER

Principal Investigators

  • D Bradley Welling, MD, PhD · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2026-08-30
Completion
2026-12-30
FDA Drug
Yes

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 NCT06448039 on ClinicalTrials.gov