Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000758707p
Ethics application status
Submitted, not yet approved
Date submitted
16/05/2022
Date registered
27/05/2022
Date last updated
27/05/2022
Date data sharing statement initially provided
27/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Volumetric bioabsorable scaffold with Vital Autologous fat graft for post-mastectomy patients desiring breast reconstruction without a permanent implant.
Scientific title
Preliminary investigation of the safety of volumetric bioabsorable scaffold with delayed vital autologous fat graft for post-mastectomy patients
Secondary ID [1] 307003 0
Nil
Universal Trial Number (UTN)
Trial acronym
The VIVA study (Volumetric bIoabsorbable scaffold with Vital
Autologous fat graft)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast reconstruction of post-mastectomy participants, for breast cancer or cancer prophylaxis. 326120 0
Condition category
Condition code
Surgery 323443 323443 0 0
Other surgery
Cancer 323709 323709 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational device is a three-dimensional dome made from poly-4-hydroxybutyrate (P4HB). This 3-D P4HB Scaffold has been developed for use in breast reconstruction. Typical mastectomy and reconstruction surgery takes up to 3 hours per breast with silicone, saline, or tissue expanders. The use of the Scaffold will take less time than it takes to place a silicone implant, saline implant, or tissue expander. Implanting the Scaffold would be significantly shorter than an autologous breast reconstruction which may require over 7 hours of surgery. Surgeons will be trained several weeks prior to the first implantation of the Scaffold. The training is not complex compared to typical reconstruction. The operative reports and clinical elements will be monitored to ensure adherence to the appropriate treatment. 100% of the information collected in the study will be monitored. This dome, or Scaffold, is fully absorbable over 12 to 18 months and meant to be implanted immediately following a mastectomy. Autologous fat transfer [AFT] is performed to supplement the volume restoration of the post-mastectomy breast from 1 to 3 times based on the patient's desired outcome.
Intervention code [1] 323447 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331180 0
Preliminary Safety of the 3-D P4HB Scaffold as measured by the per patient incidence of:

- Breast Surgical Site Infection requiring oral or IV antibiotics (review of medical records)
- Fluid / seroma requiring > 1 drainage procedure (review of medical records)
- Any breast reoperation (review of medical records)
- Re-hospitalization related to breast surgery (review of medical records)

These safety events will be analyzed as a Composite Endpoint per patient incidence. They will also be analyzed separately as secondary endpoints per patient and per breast as applicable.
Timepoint [1] 331180 0
12 months post mastectomy
Secondary outcome [1] 409099 0
Preliminary Efficacy of the 3-D P4HB Scaffold measured by the BREAST-Q© Reconstruction Module for the Physical well-being (chest) assessed individually using BREAST-Q© patient surveys.
Timepoint [1] 409099 0
Baseline (before mastectomy)
12 months post-mastectomy
Annually (on the anniversary of mastectomy) through 5 years
Secondary outcome [2] 409957 0
Preliminary Efficacy of the 3-D P4HB Scaffold measured by the BREAST-Q© Reconstruction.
Module for the Psychosocial well-being assessed individually using BREAST-Q© patient surveys.
Timepoint [2] 409957 0
Baseline (before mastectomy)
12 months post-mastectomy
Annually (on the anniversary of mastectomy) through 5 years
Secondary outcome [3] 409958 0
Preliminary Efficacy of the 3-D P4HB Scaffold measured by the BREAST-Q© Reconstruction.
Module for the Sexual well-being assessed individually using BREAST-Q© patient surveys.
Timepoint [3] 409958 0
Baseline (before mastectomy)
12 months post-mastectomy
Annually (on the anniversary of mastectomy) through 5 years
Secondary outcome [4] 409959 0
Preliminary Efficacy of the 3-D P4HB Scaffold measured by the BREAST-Q© Reconstruction.
Module for the Satisfaction with breast(s) assessed individually using BREAST-Q© patient surveys.
Timepoint [4] 409959 0
Baseline (before mastectomy)
12 months post-mastectomy
Annually (on the anniversary of mastectomy) through 5 years
Secondary outcome [5] 409960 0
Preliminary Efficacy of the 3-D P4HB Scaffold measured by the BREAST-Q© Reconstruction.
Module for the Satisfaction with implant(s) assessed individually using BREAST-Q© patient surveys.
Timepoint [5] 409960 0
Baseline (before mastectomy)
12 months post-mastectomy
Annually (on the anniversary of mastectomy) through 5 years

Eligibility
Key inclusion criteria
Participants will be recruited from the existing pool of women seeking surgical breast cancer reconstruction following mastectomy for cancer or cancer prophylaxis by the primary investigator and their colleagues.

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Female (at birth) >21 years and <70 of age
2. Participants with planned immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral) for cancer or cancer prophylaxis
3. Willing and able to provide written informed consent
4. Willing and able to comply with the study procedures and follow-up
Minimum age
22 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant is unwilling to undergo at least 1 AFT procedure after their reconstruction.
2. Participants with triple-negative, inflammatory breast cancer, HER2+, Paget disease of the
breast, node positive disease, or T-3 tumors.
3. Participants requiring pre or post-mastectomy chemotherapy or radiation therapy.
4. Participants with pathology positive margins and any patient scheduled for radiation therapy
upon definitive pathology.
5. Known allergy to tetracycline hydrochloride and kanamycin sulfate (when found after
production of P4HB, these antibiotic quantities presented as < 0.1ppm for tetracycline and <
0.1ppm for kanamycin. They are not always able to be detected).
6. Has undergone prior chest radiation treatment.
7. Participants that are Nx preoperative and have positive sentinel node on frozen section at
mastectomy.
8. Patients undergoing an axillary node dissection.
9. Has received neoadjuvant chemotherapy within the last 12 months.
10. The surgeon performing the breast reconstruction may also deem a patient ineligible if
intraoperatively there is evidence of significant mastectomy flap ischemia prior to the
initiation of the breast reconstruction procedure as evaluated clinically or with the SPY
fluorescence imaging system (Stryker Corporation, Kalamazoo, MI USA) or other
perfusion assessment.

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
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311314 0
Commercial sector/Industry
Name [1] 311314 0
Becton Dickinson Pty Ltd
Country [1] 311314 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Becton Dickinson Pty Ltd
Address
Level 5, 66 Waterloo Road
Macquarie Park
NSW, 2113
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 312685 0
None
Name [1] 312685 0
Address [1] 312685 0
Country [1] 312685 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310817 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 310817 0
Level 2
South West
300 - Grattan Street, Parkville
Victoria
Post code: 3050
Ethics committee country [1] 310817 0
Australia
Date submitted for ethics approval [1] 310817 0
23/02/2022
Approval date [1] 310817 0
Ethics approval number [1] 310817 0

Summary
Brief summary
Mastectomy (breast removal) and reconstruction surgery is a common treatment and preventative measure for women who have or are at risk of developing breast cancer. Reconstruction of the breast using artificial implants is common but not without risks. This study aims to investigate the safety of a novel 3D bio-scaffold device that can be implanted together with the patient's own fat tissue for reconstruction of the breast post-mastectomy.

Who is it for?
You may be eligible for this study if you are an adult woman aged between 22 and 69 years of age who is scheduled to undergo a mastectomy and breast reconstruction surgery either for confirmed breast cancer, or as a precautionary measure for the prevention of breast cancer.

Study details
All participants who choose to enroll in this study will undergo a mastectomy (breast removal) and reconstruction surgery. During the reconstruction surgery, rather than inserting an implant the surgeon will insert a 3D bio-scaffold that is designed to give shape to the breast. After an initial month of recovery, fat from other regions of the body will be transplanted to the scaffold to create the breast shape. It is anticipated that the bio-scaffold will absorb into the body over the 12-18 months post-surgery. All participants will be asked to complete a series of questionnaires at yearly intervals for up to 5 years post-surgery. These are anticipated to take no more than 20 minutes at each yearly interval.

It is hoped this research will contribute to the process development of new interventions to help other women facing breast reconstruction after breast loss. Participants may also benefit from an overall improved self-assessment of their body image as liposuction from areas with excess fat is needed for redistribution to their breast mound.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118966 0
Dr Michael Findlay
Address 118966 0
Peter MacCallum Cancer Centre
Department of Cancer Surgery
Level 7
305 Grattan Street
Parkville, Victoria
Postcode: 3070
Country 118966 0
Australia
Phone 118966 0
+61408706848
Fax 118966 0
Email 118966 0
Michael.Findlay@petermac.org
Contact person for public queries
Name 118967 0
Dr Michael Findlay
Address 118967 0
Peter MacCallum Cancer Centre
Department of Cancer Surgery
Level 7
305 Grattan Street
Parkville, Victoria
Postcode: 3070
Country 118967 0
Australia
Phone 118967 0
+61408706848
Fax 118967 0
Email 118967 0
Michael.Findlay@petermac.org
Contact person for scientific queries
Name 118968 0
Mr Thomas Christensen
Address 118968 0
Becton Dickinson Pty Ltd
Level 5, 66 Waterloo Road
Macquarie Park
NSW- 2113
Country 118968 0
Australia
Phone 118968 0
+61455263296
Fax 118968 0
Email 118968 0
Thomas.christensen2@bd.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study monitors and auditors who may work for the study sponsor BD or its authorized representatives, who will review deidentified data to ensure the study is being performed correctly and information recorded is accurate. Ethics committee members that approved this study to ensure participants rights and well being are safeguarded. National and international regulatory agency authorities involved in keeping research safe for participants. Summary data will be published and presented at a conference.


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.