Repair of Symptomatic Ear Drum Perforations: A Pilot Study Using Celgro Trademark Type I/III Collagen Bioscaffold

Phase 1

Recruiting

• Conditions: chronic tympanic membrane perforations; Ear - Other ear disorders

• Registration Number: ACTRN12614000532606
• Lead Sponsor: Orthocell Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Adult patients with chronic tympanic membrane perforations

Exclusion Criteria

< 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tympanic membrane wound healing will be assessed visually recording colour, transparency, blood vessels and perforation size. Photodocumentation will be used. [Every week for the first month then at 3, 6 and 12 months];Hearing outcomes will be measured by an audiology assessment that measures Frequency Threshold, Pure Tone Average and Air-Bone Gap. [Every week for the first month then at 3, 6 and 12 months<br>]

Secondary Outcome Measures

Name	Time	Method
il[Nil]