In-office Repair of Chronic Tympanic Membrane Perforations

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 15, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

December 30, 2025

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.

Trial Locations (1)

02214

Massachusetts Eye and Ear, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Nobelpharma

INDUSTRY

lead

D. Bradley Welling, MD, PhD

OTHER

NCT06448039 - In-office Repair of Chronic Tympanic Membrane Perforations | Biotech Hunter | Biotech Hunter