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Trial registered on ANZCTR


Registration number
ACTRN12613000877785
Ethics application status
Not yet submitted
Date submitted
31/07/2013
Date registered
7/08/2013
Date last updated
7/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of tissue expanders for breast reconstruction – what you put in is not always what you get out! A Pilot study of Tissue Expander fill and final volumes
Scientific title
The use of tissue expanders for breast reconstruction – what you put in is not always what you get out! A Pilot study of Tissue Expander fill and final volumes in women undergoing breast reconstruction after mastectomy
Secondary ID [1] 282940 0
nil known
Universal Trial Number (UTN)
U1111-1146-2138
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pilot study involving the volumes of tissue expanders used in breast cancer related reconstructive surgeries 289760 0
Condition category
Condition code
Surgery 290100 290100 0 0
Surgical techniques
Cancer 290131 290131 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessing the difference in the fill volumes inserted into a tissue expander and the final volumes on removal of the tissue expander. A descrepency has been noted that will effect the size of the second stage implant that is inserted into the sub-pectoral pocket and thus the cosmetic outcome.
Type of Tissue expanders studied: 133MV Allergan style tissue expanders
The tissue expander is assessed at the time of second stage reconstruction which is usually anywhere between 3-4 months after the initial insertion.
Intervention code [1] 287665 0
Not applicable
Comparator / control treatment
no control used
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290141 0
Difference in the volumes noted effect the size of the implant that is inserted into the sub-pectoral pocket. Surgeons should be aware of this descrepency and have a wide range of implant sizes available at the time of the second stage reconstructive surgery.
The fill volume is based on the total amount of normal saline inserted into the tissue expanders by the surgeon (intra-operatively at the 1st stage and at office based insertions
The final volume is measured in 2 ways; by volume displacement by placing the removed TE into a graduated beaker containing 500ml of fluid as well by weighing the TE itself.
Timepoint [1] 290141 0
This is a pilot study of 32 tissue expanders evaluated in a 6 month period. An extension is planned.
Volume is measured at the time of the second stage implant reconstruction
Secondary outcome [1] 304008 0
The fill volume is based on the total amount of normal saline inserted into the tissue expanders by the surgeon (intra-operatively at the 1st stage and at office based insertions
The final volume is measured in 2 ways; by volume displacement by placing the removed TE into a graduated beaker containing 500ml of fluid as well by weighing the TE itself.
To postulate the cause of this decrepency - we assessed the biochemistry of the fluid within the tissue expanders at the 2nd stage surgery to determine if there was ingress of plasma into the normal saline that was inserted and we did find small amounts of plasma constituents; this points towards a defect in the valves. Other investigators have also assessed the valve mechanisms, osmotic gradients across the membranes and colloid osmotic swelling.
Timepoint [1] 304008 0
6 months

Eligibility
Key inclusion criteria
All patients undergoing Tissue expander/Implant based breast reconstruction after mastectomy - 6 month period in 2012
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Ruptured/leaking tissue expanders

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data was collected in an Excel 2010 workbook and analysed using NCSS software. A paired t-test was used to compare volumes and a p value of <0.05 considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1369 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 1370 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 7231 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 287716 0
Self funded/Unfunded
Name [1] 287716 0
no funding was required
Address [1] 287716 0
not applicable
Country [1] 287716 0
Primary sponsor type
Individual
Name
Dr Ananda Kallyani S M Ponniah
Address
Breast Centre
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 286446 0
None
Name [1] 286446 0
Address [1] 286446 0
Country [1] 286446 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289672 0
Ethics Comittee/unit
Ethics committee address [1] 289672 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Ethics committee country [1] 289672 0
Australia
Date submitted for ethics approval [1] 289672 0
30/07/2013
Approval date [1] 289672 0
Ethics approval number [1] 289672 0

Summary
Brief summary
The primary purpose of this study is to evaluate tissue expander fill and final volumes in women undergoing breast reconstruction. Who is it for? This study included women who underwent tissue expander/implant based breast reconstruction following mastectomy. The surgeries were conducted over a 6 month period in 2012. Trial details All participants in this study underwent breast reconstruction surgery with tissue expander. The tissue expander fill volume inserted at the time of first implant was compared to the final volume on removal of the tissue expander at the time of second stage reconstructions (about 3-4 months later). A discrepancy between these values affects the size of the second stage implant and thus the cosmetic outcome.
Trial website
Trial related presentations / publications
Public notes
As the study does not involve human or animal tissue a formal ethical approval may not be necessary; however the study has been referred to the ethical comittee in Sir Charles Gairdner Hospital and we are awaiting their feedback

Contacts
Principal investigator
Name 41890 0
Dr Ananda Kallyani S M Ponniah
Address 41890 0
The Breast Centre
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
WA
Country 41890 0
Australia
Phone 41890 0
+61405219079
Fax 41890 0
Email 41890 0
ananda_ponniah@yahoo.com
Contact person for public queries
Name 41891 0
Dr Ananda Kallyani S M Ponniah
Address 41891 0
The Breast Centre
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
WA
Country 41891 0
Australia
Phone 41891 0
+61405219079
Fax 41891 0
Email 41891 0
ananda_ponniah@yahoo.com
Contact person for scientific queries
Name 41892 0
Dr Ananda Kallyani S M Ponniah
Address 41892 0
The Breast Centre
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
WA
Country 41892 0
Australia
Phone 41892 0
+61405219079
Fax 41892 0
Email 41892 0
ananda_ponniah@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary