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

Not Applicable

Recruiting

• Conditions: Ear Drum Perforations; Ear - Other ear disorders

• Registration Number: ACTRN12613001338752
• Lead Sponsor: Otolaryngology,Head & Neck Surgery, UWA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of successful perforation closure will be assessed using videootoscopy with photographic capture of the perforation site at every follow up after surgery. The size of the preoperative perforation and any residual perforation post surgery will be measured using image analysis software (J image) [12 months after intervention]

Secondary Outcome Measures

Name	Time	Method
Effects on Hearing thresholds with successful closure of the Air-bone gap. This will assessed using standard audiometers to measure pure tone average thresholds after documented closure of the perforation post surgery[Hearing thresholds after 12 months post-interventon]