FGF2 for Perforated Eardrum

Overseen by D. Bradley Welling, MD, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: D. Bradley Welling, MD, PhD

Trial Summary

What is the purpose of this trial?

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.

Research Team

D. Bradley Welling, MD, PhD

Principal Investigator

Massachusetts Eye and Ear Infirmary

Eligibility Criteria

This trial is for individuals with chronic tympanic membrane (eardrum) perforations. It's an extension of a previous study aiming to improve healing success rates.

Inclusion Criteria

Confirmed tympanic membrane perforation for 6 months or longer

Confirmed central perforation

I am 12 years old or older.

Exclusion Criteria

I currently have an ear infection.

I have had radiation treatment before.

I had ear surgery before, but it didn't work.

Treatment Details

Interventions

• Fibroblast Growth Factor 2 (Growth Factor)

Trial Overview The trial compares the effectiveness of fibroblast growth factor 2 (FGF2) versus saline in healing eardrum perforations. Twenty participants will be randomly assigned to receive either FGF2 or saline at a ratio of 3:1.

Participant Groups

Group I: FGF2 active arm Experimental Treatment 1 Intervention

Active 0.1-0.2 ml of FGF2 will be placed on gelatin sponge in middle ear and on the lateral surface of the tympanic membrane and then covered with fibrin glue.

Group II: Saline control Placebo Group 1 Intervention

0.1-0.2 ml of normal sterile saline will be placed on gelatin sponge in middle ear and on the lateral surface of the tympanic membrane and then covered with fibrin glue.

Who Is Running the Clinical Trial?

D. Bradley Welling, MD, PhD

Lead Sponsor

Trials

1

Recruited

20+

Nobelpharma

Industry Sponsor

Trials

36

Recruited

2,200+