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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001338752

Enrollment

Registered

2013-12-06

Start date

2012-02-08

Completion date

2015-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

5 Years to 95 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results