RecruitingACTRN12613001338752

Tissue-engineered Regeneration of Tympanic Membrane (Ear Drum) Perforations

Regeneration of tympanic membrane (ear drum) perforations using b-fibroblast growth factor and the impact on perforation closure rates and hearing outcomes


Sponsor

Otolaryngology,Head & Neck Surgery, UWA

Enrollment

60 participants

Start Date

Feb 8, 2012

Study Type

Interventional

Conditions

Summary

To investigate the effects of bFGF on treatment of chronic ear drum perforations


Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 95 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment for chronic (long-lasting) holes in the eardrum (tympanic membrane perforations). The treatment uses a growth factor called bFGF (basic fibroblast growth factor) to try to help the eardrum heal itself. A scaffold material is also used to support the healing tissue. You may be eligible if: - You are aged between 5 and 95 years - You have a dry eardrum perforation (hole in the eardrum with no active infection) - The hole is 50% or less of the total eardrum surface You may NOT be eligible if: - You have an active middle ear infection - You have had ear discharge in the last 3 months - You have an allergy to bFGF or the scaffold material - You have problems with the tiny bones in the middle ear (ossicular chain pathology) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Surgical freshening of the perforation edges, followed by measurement of the perforation size. After this sizing of the scaffold to the dimensions of the perforation and introduction of the scaffold i

Surgical freshening of the perforation edges, followed by measurement of the perforation size. After this sizing of the scaffold to the dimensions of the perforation and introduction of the scaffold into the perforation sothat there is a snug fit of the scaffold in the perforation. Now application of human Fibroblast Growth Factor (FGF), followed by the blood seal and histoacryl cap. The entire procedure will take around 10 minutes.


Locations(2)

Fremantle Hospital and Health Service - Fremantle

WA, Australia

Princess Margaret Hospital - Subiaco

WA, Australia

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ACTRN12613001338752