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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
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Scientific title
Repair of Symptomatic Ear Drum Perforations: A Pilot Study Using Celgro Trademark Type I/III Collagen Bioscaffold
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Secondary ID [1]
282530
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Nil
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Universal Trial Number (UTN)
U1111-1143-2851
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic tympanic membrane perforations
289195
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Condition category
Condition code
Ear
289523
289523
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0
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Other ear disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287194
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Treatment: Devices
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Intervention code [2]
289413
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Treatment: Surgery
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
289622
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Tympanic membrane wound healing will be assessed visually recording colour, transparency, blood vessels and perforation size. Photodocumentation will be used.
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Assessment method [1]
289622
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Timepoint [1]
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Every week for the first month then at 3, 6 and 12 months
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Primary outcome [2]
289623
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Hearing outcomes will be measured by an audiology assessment that measures Frequency Threshold, Pure Tone Average and Air-Bone Gap.
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Assessment method [2]
289623
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Timepoint [2]
289623
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Every week for the first month then at 3, 6 and 12 months
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Secondary outcome [1]
302881
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Nil
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Assessment method [1]
302881
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Timepoint [1]
302881
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Nil
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Eligibility
Key inclusion criteria
Adult patients with chronic tympanic membrane perforations
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
< 18 years
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/02/2014
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Actual
27/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
1437
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Fremantle Hospital and Health Service - Fremantle
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Funding & Sponsors
Funding source category [1]
287774
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Hospital
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Name [1]
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Fremantle Hospital
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Address [1]
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Alma St, Fremantle, Western Australia 6160
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Country [1]
287774
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Orthocell Ltd
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Address
Building 191 Murdoch University,
90 South St,
Murdoch,
WA 6150
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Country
Australia
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Secondary sponsor category [1]
286501
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None
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Name [1]
286501
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Address [1]
286501
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Country [1]
286501
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Other collaborator category [1]
277576
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University
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Name [1]
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The University of Western Australia
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Address [1]
277576
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35 Stirling Hwy,
Crawley,
WA 6009
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Country [1]
277576
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289724
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
289724
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Demountable 3, G Block,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6959
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Ethics committee country [1]
289724
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Australia
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Date submitted for ethics approval [1]
289724
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Approval date [1]
289724
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15/04/2013
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Ethics approval number [1]
289724
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12/349
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
40182
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Prof Gunesh Rajan
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Address
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C/o Department of Otolaryngology, Head and Neck Surgery,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6160
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Country
40182
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Australia
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Phone
40182
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+61894312500
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Fax
40182
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Email
40182
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[email protected]
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Contact person for public queries
Name
40183
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Prof Gunesh Rajan
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Address
40183
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C/o Department of Otolaryngology, Head and Neck Surgery,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6160
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Country
40183
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Australia
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Phone
40183
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+61894312500
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Fax
40183
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Email
40183
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[email protected]
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Contact person for scientific queries
Name
40184
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Prof Gunesh Rajan
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Address
40184
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C/o Department of Otolaryngology, Head and Neck Surgery,
Fremantle Hospital,
Alma St,
Fremantle,
WA 6160
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Country
40184
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Australia
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Phone
40184
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+61894312500
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Fax
40184
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Email
40184
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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