In-office Repair of Chronic Tympanic Membrane Perforations

NCT06448039 | Suspended Phase 1 FDA Drug

• 1 other identifier: 2024P001401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibroblast growth factor type 2

Outcome Measures

Primary Outcomes (2)

• Complete closure of tympanic membrane perforation

  Complete closure of tympanic membrane perforation by otoscopic examination and documented with photography

  Six months

• Tympanometry

  Closure of perforation will be documented by normal volumes

  Six months

Secondary Outcomes (1)

• Hearing

  6 months

Study Arms (2)

FGF2 active arm

EXPERIMENTAL

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.

Drug: Fibroblast Growth Factor 2

Saline control

PLACEBO COMPARATOR

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.

Drug: Saline control

Interventions

Fibroblast Growth Factor 2 DRUG

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.

Also known as: FGF2

FGF2 active arm

Saline control DRUG

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.

Saline control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older.
• Confirmed tympanic membrane perforation for more 6 months or longer.
• Confirmed dry perforation.
• Confirmed central perforation.
• Ability to provide informed consent.

You may not qualify if:

• Patient is receiving or has a prior history of radiation treatment.
• Prior tympanoplasty with failure.
• Currently use of corticosteroids, immunosuppressive agents, or chemotherapy.
• Active middle ear infection or inflammation on otoscopic examination

Sponsors & Collaborators

• D. Bradley Welling, MD, PhD: lead
• Nobelpharma: collaborator

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02214, United States

Location

Related Publications (3)

• Santos F, Shu E, Lee DJ, Jung DH, Quesnel AM, Stankovic KM, Abdul-Aziz DE, Bay CP, Quinkert A, Welling DB. Topical fibroblast growth factor-2 for treatment of chronic tympanic membrane perforations. Laryngoscope Investig Otolaryngol. 2020 May 14;5(4):657-664. doi: 10.1002/lio2.395. eCollection 2020 Aug.

  PMID: 32864435 BACKGROUND

• Hakuba N, Iwanaga M, Tanaka S, Hiratsuka Y, Kumabe Y, Konishi M, Okanoue Y, Hiwatashi N, Wada T. Basic fibroblast growth factor combined with atelocollagen for closing chronic tympanic membrane perforations in 87 patients. Otol Neurotol. 2010 Jan;31(1):118-21. doi: 10.1097/MAO.0b013e3181c34f01.

  PMID: 19940793 BACKGROUND

• Kanemaru S, Umeda H, Kitani Y, Nakamura T, Hirano S, Ito J. Regenerative treatment for tympanic membrane perforation. Otol Neurotol. 2011 Oct;32(8):1218-23. doi: 10.1097/MAO.0b013e31822e0e53.

  PMID: 21897328 BACKGROUND

MeSH Terms

Interventions

Fibroblast Growth Factor 2

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• D Bradley Welling, MD, PhD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and providers will not be aware of treatment assignment until the conclusion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Double blinded placebo controlled trial

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)