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Trial registered on ANZCTR


Registration number
ACTRN12614000532606
Ethics application status
Approved
Date submitted
16/05/2014
Date registered
20/05/2014
Date last updated
20/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Repair of Symptomatic Ear Drum Perforations: A Pilot Study Using Celgro Trademark Type I/III Collagen Bioscaffold
Scientific title
Repair of Symptomatic Ear Drum Perforations: A Pilot Study Using Celgro Trademark Type I/III Collagen Bioscaffold
Secondary ID [1] 282530 0
Nil
Universal Trial Number (UTN)
U1111-1143-2851
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic tympanic membrane perforations 289195 0
Condition category
Condition code
Ear 289523 289523 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Celgro Trademark Type I/III Collagen Bioscaffold.

The Type I/III Collagen Bioscaffold is circumferentially grafted onto the tympanic membrane perforation edge.

The procedure is expected to take approximately 15 minutes and it undertaken on a single occasion only.

Participants receive a local anaesthetic for this procedure.
Intervention code [1] 287194 0
Treatment: Devices
Intervention code [2] 289413 0
Treatment: Surgery
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289622 0
Tympanic membrane wound healing will be assessed visually recording colour, transparency, blood vessels and perforation size. Photodocumentation will be used.
Timepoint [1] 289622 0
Every week for the first month then at 3, 6 and 12 months
Primary outcome [2] 289623 0
Hearing outcomes will be measured by an audiology assessment that measures Frequency Threshold, Pure Tone Average and Air-Bone Gap.
Timepoint [2] 289623 0
Every week for the first month then at 3, 6 and 12 months
Secondary outcome [1] 302881 0
Nil
Timepoint [1] 302881 0
Nil

Eligibility
Key inclusion criteria
Adult patients with chronic tympanic membrane perforations
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
< 18 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
27/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1437 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 287774 0
Hospital
Name [1] 287774 0
Fremantle Hospital
Country [1] 287774 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell Ltd
Address
Building 191 Murdoch University,
90 South St,
Murdoch,
WA 6150
Country
Australia
Secondary sponsor category [1] 286501 0
None
Name [1] 286501 0
Address [1] 286501 0
Country [1] 286501 0
Other collaborator category [1] 277576 0
University
Name [1] 277576 0
The University of Western Australia
Address [1] 277576 0
35 Stirling Hwy,
Crawley,
WA 6009
Country [1] 277576 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289724 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 289724 0
Demountable 3, G Block,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6959
Ethics committee country [1] 289724 0
Australia
Date submitted for ethics approval [1] 289724 0
Approval date [1] 289724 0
15/04/2013
Ethics approval number [1] 289724 0
12/349

Summary
Brief summary
More than 106,000 Australians suffer from hearing loss and chronic ear infections related to perforations of the ear drum. Closure of these perforations traditionally requires surgery lasting up to an hour or more under general anaesthesia. Conventional myringoplasty has closure rates of ~85% in non-Indigenous populations and 50-70% in Indigenous populations. This project validates a new approach for closure of perforations requiring minimal surgery. Adults are treated under local anaesthesia with a Celgro Trademark Type I/III Collagen Bioscaffold mixed with fibrin glue placed into the perforation, thereby promoting the self-healing capacity of the eardrum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40182 0
Prof Gunesh Rajan
Address 40182 0
C/o Department of Otolaryngology, Head and Neck Surgery,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6160
Country 40182 0
Australia
Phone 40182 0
+61894312500
Fax 40182 0
Email 40182 0
[email protected]
Contact person for public queries
Name 40183 0
Gunesh Rajan
Address 40183 0
C/o Department of Otolaryngology, Head and Neck Surgery,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6160
Country 40183 0
Australia
Phone 40183 0
+61894312500
Fax 40183 0
Email 40183 0
[email protected]
Contact person for scientific queries
Name 40184 0
Gunesh Rajan
Address 40184 0
C/o Department of Otolaryngology, Head and Neck Surgery,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6160
Country 40184 0
Australia
Phone 40184 0
+61894312500
Fax 40184 0
Email 40184 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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