Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000147785
Ethics application status
Approved
Date submitted
2/12/2021
Date registered
28/01/2022
Date last updated
6/07/2024
Date data sharing statement initially provided
28/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial evaluating medical-grade polycaprolactone-PCL breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery
Scientific title
Clinical trial evaluating feasibility and safety of medical-grade polycaprolactone-PCL breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery
Secondary ID [1] 305929 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast implant revision 324525 0
Congenital defect correction 324552 0
Condition category
Condition code
Surgery 321992 321992 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted for breast revision an/or congenital defect correction.

First the patient will be thoroughly evaluated with history taking and examination to etermine whether they are suitable for implantation.

If deemed suitable for the trial, the surgeon together with the patient will choose the right scaffold size and fix a date for the surgery. All scaffolds are sterilized and transported in sealed packaging.

The implantation surgery will be done at a tertiary teaching hospital by an experienced breast surgeon and plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction techniques usually harvesting from the abdomen and thighs depending on availability of tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of initial implantation. The total length of procedure is estimated to take 2 hours.

Recovery from the operation can take up to one week. From that, the effectiveness, complications and side-effects will be monitored for up to two years. The patient progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status.
On discharge a number of surveys will be performed to document the progress at regular intervals, as well as MRI studies. The duration of follow up for the study is 2 years after implantation.

All appointments and clinical assessments will be documented in the electronic patient medical record as well as electronic Case Report Form (QH-REDCap database).
Intervention code [1] 322324 0
Treatment: Surgery
Intervention code [2] 322325 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329748 0
Feasibility assessed through post-operative device safety measured through the adverse device effect rate (ADE rate). Adverse events are defined as per EN ISO 14155:2020. This will be regularly monitored during inpatient and outpatient follow up.
Timepoint [1] 329748 0
Assessed daily during inpatient stay, at 1-week, 2- (primary timepoint), 6-, 12- and 24-months post-surgery.
Secondary outcome [1] 403655 0
Adverse Event rate and severity. Adverse events and severity are defined as per EN ISO 14155:2020. This will be regularly monitored during inpatient and outpatient follow up.
Timepoint [1] 403655 0
Assessed daily during inpatient stay, at 1-week, 2-, 6-, 12- and 24-months post-surgery.
Secondary outcome [2] 403656 0
Frequency of complication (composite outcome of short term and long term complications). This will be regularly monitored during inpatient and outpatient follow up with a study-specific questionnaire.
Timepoint [2] 403656 0
Short term complications will be assessed at 1-week and 2-months follow-up visits, Long term complications will be assessed at 6-months, 12-months and 24-months follow-up visits,
Secondary outcome [3] 403657 0
Number of revision surgeries due to Adverse Device Effects. Adverse events are defined as per EN ISO 14155:2020. This will be regularly monitored during inpatient and outpatient follow up with a study-specific questionnaire.
Timepoint [3] 403657 0
Assessed daily during inpatient stay, at 1-week, 2-, 6-, 12- and 24-months post-surgery.
Secondary outcome [4] 403658 0
Feasibility assessed through frequency of successful breast surgeries. This will be assessed as a composite outcome of number of successful surgeries and clinical images (photographs, 3D scan, 180° video).
Timepoint [4] 403658 0
The frequency of successful breast reconstructions will be assessed at the 24-month visit.
Secondary outcome [5] 403659 0
Feasibility assessed through patient reported breast-specific outcomes, which will be measured using the BREAST-Q questionnaire.
Timepoint [5] 403659 0
Assessed at 2-, 6-, 12- and 24-months post-surgery.
Secondary outcome [6] 404499 0
Feasibility assessed through volume replacement during the study period measured through MRI (breast volume, scaffold volume and fat volume within scaffold), MRI with contrast (only at 24-month post-surgery) and: - Sternal notch to nipple (SN-N) - Breast Base Width (BBW) - Breast Height - Nipple to Inframammary Fold (N-IMF)
Timepoint [6] 404499 0
Assessed at enrolment and at 2-, 6-, 12- and 24-month post-surgery.

Eligibility
Key inclusion criteria
1. Females over the age of 18 requiring pre-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
2. Patient willing and able to comply with the study requirements.
3. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
4. Patient capable of providing valid informed consent.
5. Patient has sufficient body fat for homologous transplantation.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients may not participate in the clinical investigation if they meet ANY of the following criteria:
1. Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue.
2. Patients who have had breast or chest wall irradiation.
3. Prior history of infection in the breast region in the preceding 12 months.
4. Patients diagnosed with or having a prior history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
5. The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability.
6. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
7. Known severe concurrent or inter-current illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Co-ordinating Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.
8. Body mass Index (BMI) below 20 and above 30 (patients with a BMI above 30 may still be eligible pending assessment by investigating team and documentation of rationale).
9. Polycaprolactone (PCL) allergy
10. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the breast surgery.
11. Patient ineligible to undergo MRI.
12. Patient unable or unwilling to comply with the treatment protocol.
13. Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
14. Patients with a history of smoking (patients with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)

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/efficacy
Statistical methods / analysis
All patients consented for the trial will be accounted for in the analysis (intention to treat). Statistical analysis will include descriptive statistics for demographic, primary and secondary outcomes at each time point. Comparison analysis of questionnaire results between timepoints and time to event univariate Cox regression analysis will be performed due the small sample size. Statistical significance will be defined as P < 0.05. Data will be analysed using SPSS for Windows v.22 (SPSS, Chicago, Illinois, USA).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
15/06/2022
Date of last participant enrolment
Anticipated
2/02/2023
Actual
6/09/2023
Date of last data collection
Anticipated
17/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310272 0
Commercial sector/Industry
Name [1] 310272 0
BellaSeno Pty Ltd
Country [1] 310272 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BellaSeno Pty Ltd
Address
16 Nexus Way,
Southport
QLD 4215
Country
Australia
Secondary sponsor category [1] 311599 0
None
Name [1] 311599 0
Address [1] 311599 0
Country [1] 311599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309943 0
Metro North Health HREC A (EC00172)
Ethics committee address [1] 309943 0
Ethics committee country [1] 309943 0
Australia
Date submitted for ethics approval [1] 309943 0
17/02/2022
Approval date [1] 309943 0
19/02/2022
Ethics approval number [1] 309943 0
HREC/2021/QRBW/79906

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

Contacts
Principal investigator
Name 115930 0
Prof Owen Ung
Address 115930 0
Director, Comprehensive Breast Cancer Institute (CBCI), Metro North Health
Breast Surgeon, Royal Brisbane and Women’s Hospital, Metro North Health
Level 14, Block 7, RBWH campus, Herston Qld 4029
Country 115930 0
Australia
Phone 115930 0
+61 7 3646 0177
Fax 115930 0
Email 115930 0
Owen.Ung@health.qld.gov.au
Contact person for public queries
Name 115931 0
Michael Wagels
Address 115931 0
Plastic and Reconstructive Surgeon, Metro North Health
Clinical Director, Herston Biofabrication Institute, Level 12, Block 7, RBWH campus, 15 Butterfield Street, Herston QLD 4059
Country 115931 0
Australia
Phone 115931 0
+6173176 7934
Fax 115931 0
Email 115931 0
michael.wagels@health.qld.gov.au
Contact person for scientific queries
Name 115932 0
Owen Ung
Address 115932 0
Director, Comprehensive Breast Cancer Institute (CBCI), Metro North Health
Breast Surgeon, Royal Brisbane and Women’s Hospital, Metro North Health
Level 14, Block 7, RBWH campus, Herston Qld 4029
Country 115932 0
Australia
Phone 115932 0
+61736460177
Fax 115932 0
Email 115932 0
Owen.Ung@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14283Study protocol  Owen.Ung@health.qld.gov.au
14284Informed consent form  Owen.Ung@health.qld.gov.au
14285Ethical approval  Owen.Ung@health.qld.gov.au



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.