Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000311257
Ethics application status
Approved
Date submitted
12/02/2009
Date registered
19/05/2009
Date last updated
19/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breast reconstruction for breast asymmetry by tissue engineering
Scientific title
Breast reconstruction for breast asymmetry by tissue engineering
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast asymmetry 4326 0
Condition category
Condition code
Surgery 4561 4561 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Breast reconstruction in an implanted acrylic spacer using the body's own ability to grow new tissue to fill the empty space provided by acrylic spacer over a perioid of 3 to 6 months.
Intervention code [1] 4056 0
Treatment: Surgery
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5444 0
Improved breast symmetry. New tissue growth will be measured using Magnetic Resonance Imaging (MRI)
Timepoint [1] 5444 0
Outcome will be measured 3 months post-operatively, and after that monthly from 3-6 months post-surgery until the spacer is filled with new tissue.
Secondary outcome [1] 9141 0
Improved breast symmetry and cosmetic result, monitored clinically by plastic surgeons
Timepoint [1] 9141 0
1 year post-surgery

Eligibility
Key inclusion criteria
Breast asymmetry, unlikely suitable for other reconstructive flap methods.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous chest wall irradiation

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4498 0
Charities/Societies/Foundations
Name [1] 4498 0
Microsurgical Research Foundation
Country [1] 4498 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Microsurgical Research Foundation
Address
Bernard O'Brien Institute of Microsurgery (BOBIM)
42 Fitzroy Street
Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 4061 0
None
Name [1] 4061 0
Address [1] 4061 0
Country [1] 4061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6558 0
Human Research Ethics Committee-D St Vincent's Health Melbourne
Ethics committee address [1] 6558 0
PO Box 2900
Fitzroy Victoria 3065
Ethics committee country [1] 6558 0
Australia
Date submitted for ethics approval [1] 6558 0
Approval date [1] 6558 0
11/02/2009
Ethics approval number [1] 6558 0
156/08

Summary
Brief summary
Study hypothesis: The human body has a natural capacity to regenerate and to grow new tissue to fill an empty space. This study applies a new method of breast reconstruction using the patient’s own regenerative capacity. This method provides an alternative to current breast reconstruction techniques and also an opportunity for patients who have no other option for reconstruction. In the operation an acrylic spacer, shaped according to the breast defect, will be placed under the skin of the chest wall to allow a piece of fat with a blood supply to grow over time (3-6 months) to fill the space created by the acrylic spacer. The small piece of fat with a blood supply will be sourced from well-known existing donor sites for breast reconstruction (chest or abdomen). Because the amount of tissue is small the expected donor site scars will be smaller compared with the usual reconstruction methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29285 0
Address 29285 0
Country 29285 0
Phone 29285 0
Fax 29285 0
Email 29285 0
Contact person for public queries
Name 12532 0
Prof Wayne Morrison
Address 12532 0
BOBIM
42 Fitzroy Street
Fitzroy, VIC 3065
Country 12532 0
Australia
Phone 12532 0
+61 3 9288 2549
Fax 12532 0
Email 12532 0
Wayne.MORRISON@svhm.org.au
Contact person for scientific queries
Name 3460 0
Prof Wayne Morrison
Address 3460 0
St Vincents Hospital Melbourne
41 Victoria Pde
Fitzroy, VIC 3065
Country 3460 0
Australia
Phone 3460 0
+61 3 9288 2549
Fax 3460 0
Email 3460 0
Wayne.MORRISON@svhm.org.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.