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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

Ear Drum Perforations

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

Inclusion Criteria1

  • dry ear drum perforation; perforation size smaller or equal to 50% percent of the drum surface

Exclusion Criteria4

  • active middle ear infection
  • ear discharge in the last 3 months
  • allergy to bFGF or scaffold
  • associated ossicular chain pathology

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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