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Trial registered on ANZCTR


Registration number
ACTRN12613001338752
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
6/12/2013
Date last updated
6/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tissue-engineered Regeneration of Tympanic Membrane (Ear Drum) Perforations
Scientific title
Regeneration of tympanic membrane (ear drum) perforations using b-fibroblast growth factor and the impact on perforation closure rates and hearing outcomes
Secondary ID [1] 282111 0
CTN 2012/0090 by Therapeutics Goods Administration (TGA)
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ear Drum Perforations 288606 0
Condition category
Condition code
Ear 288938 288938 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286712 0
Treatment: Surgery
Comparator / control treatment
Comparison of fibroblast growth factor(FGF) in combination with various scaffolds and by itself. 3 different scaffolds will be used, the surgical technique is the same with all the scaffolds so there will not be any change in duration of the intervention. The scaffolds compared will be: Gelfoam;collagen; fibroin. The control group consists of using the fibroblast growth factor on its own.
Control group
Active

Outcomes
Primary outcome [1] 289064 0
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)
Timepoint [1] 289064 0
12 months after intervention
Secondary outcome [1] 301664 0
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
Timepoint [1] 301664 0
Hearing thresholds after 12 months post-interventon

Eligibility
Key inclusion criteria
dry ear drum perforation; perforation size smaller or equal to 50% percent of the drum surface
Minimum age
5 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
active middle ear infection
ear discharge in the last 3 months
allergy to bFGF or scaffold
associated ossicular chain pathology

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
closed envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
8/02/2012
Date of last participant enrolment
Anticipated
30/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 733 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 734 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 286878 0
University
Name [1] 286878 0
Otolaryngology,Head & Neck Surgery, UWA
Country [1] 286878 0
Australia
Primary sponsor type
University
Name
Otolaryngology,Head & Neck Surgery, UWA
Address
Level 6, T-Block
Fremantle Hospital Campus
Alma Street
Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 285669 0
None
Name [1] 285669 0
Address [1] 285669 0
Country [1] 285669 0
Other collaborator category [1] 277319 0
Individual
Name [1] 277319 0
Prof.Shin-Ichi Kanemaru
Address [1] 277319 0
Kobe University Hospital
7-5-2 Kusunoki-cho,
Chuo-ku, Kobe 650-0017 Japan
Country [1] 277319 0
Japan
Other collaborator category [2] 277711 0
Individual
Name [2] 277711 0
Professor Harvey Coates
Address [2] 277711 0
ENT Department
Princess Margareth Hospital
Roberts Road
Subiaco 6008 WA
Country [2] 277711 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288941 0
FHHS Ethics committee
Ethics committee address [1] 288941 0
Ethics committee country [1] 288941 0
Australia
Date submitted for ethics approval [1] 288941 0
Approval date [1] 288941 0
Ethics approval number [1] 288941 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38430 0
Prof Gunesh Rajan
Address 38430 0
Otolaryngology,Head & Neck Surgery, School of Surgery,
Level 6, T-Block
Fremantle Hospital Campus
Alma Street
Fremantle WA 6160
Country 38430 0
Australia
Phone 38430 0
+61894312500
Fax 38430 0
Email 38430 0
alison.wallace@uwa.edu.au
Contact person for public queries
Name 38431 0
Alison Wallace
Address 38431 0
Otolaryngology,Head & Neck Surgery, School of Surgery,
Level 6, T-Block
Fremantle Hospital Campus
Alma Street
Fremantle WA 6160
Country 38431 0
Australia
Phone 38431 0
+61894312500
Fax 38431 0
Email 38431 0
alison.wallace@uwa.edu.au
Contact person for scientific queries
Name 38432 0
Gunesh Rajan
Address 38432 0
Otolaryngology,Head & Neck Surgery, School of Surgery,
Level 6, T-Block
Fremantle Hospital Campus
Alma Street
Fremantle WA 6160
Country 38432 0
Australia
Phone 38432 0
+61894312500
Fax 38432 0
Email 38432 0
alison.wallace@uwa.edu.au

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.