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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05437757




Registration number
NCT05437757
Ethics application status
Date submitted
16/06/2022
Date registered
29/06/2022
Date last updated
11/01/2024

Titles & IDs
Public title
Scaffold-guided Breast Surgery
Scientific title
Clinical Trial Evaluating Medical-grade Polycaprolactone-PCL Breast Scaffold Implantation With Autologous Fat Grafting for Breast Implant Revision and Congenital Defect Correction Surgery
Secondary ID [1] 0 0
2021-BRV-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Implant Revision 0 0
Congenital Breast Defect Correction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Surgical implantation of the PCL Breast scaffold with autologous fat grafting

Experimental: Implantation of PCL Breast scaffold - Insertion of a 3D printed medical-grade polycaprolactone-PCL Breast scaffold with autologous fat graft for unilateral or bilateral breast implant revision and congenital defect correction surgery.


Treatment: Devices: Surgical implantation of the PCL Breast scaffold with autologous fat grafting
Single shot of prophylactic perioperative antibiotics is given to the patient. A suitable incision is made to provide access followed by mobilisation of the breast gland.If present, the silicone implant is removed and capsulectomy performed. The implant pocket shall be rinsed with saline or antiseptic and a surgical drain shall be placed in the pocket at the discretion of the PI. The PCL Breast scaffold shall be inserted into the pocket and fixed using 2 to 4 sutures. The incision is closed. Liposuction is performed from another area of the body and lipofilling is performed within the breast scaffold. Sterile bandaging is applied and a daily wound revision is performed whilst an inpatient. A prophylactic antibiotic shall be administered to the patient.The patients shall be hospitalized overnight for clinical observation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post-operative device safety
Timepoint [1] 0 0
Assessed daily during inpatient stay at 1-week, 2-,6-,12- and 24-months post-surgery.
Secondary outcome [1] 0 0
Adverse Event rate and severity
Timepoint [1] 0 0
Assessed daily during inpatient stay at 1-week, 2-,6-,12- and 24-months post-surgery.
Secondary outcome [2] 0 0
Frequency of complication
Timepoint [2] 0 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] 0 0
Number of revision surgeries due to Adverse Device Effects
Timepoint [3] 0 0
Assessed daily during inpatient stay, at 1-week, 2-,6-,12- and 24-months post-surgery.
Secondary outcome [4] 0 0
Feasibility assessed through frequency of successful breast surgeries
Timepoint [4] 0 0
The frequency of successful breast surgeries will be assessed at the 24-month visit. The outcome of the surgeries will be assessed at enrolment and at 1-week, 2-, 6-, 12- and 24-month post-surgery.
Secondary outcome [5] 0 0
Feasibility assessed through patient reported breast-specific outcomes
Timepoint [5] 0 0
Assessed at 2-,6-,12- and 24-months post-surgery.
Secondary outcome [6] 0 0
Feasibility assessed through volume replacement
Timepoint [6] 0 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
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
Other
Allocation to intervention
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2025
Actual
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital (RBWH) - Brisbane
Recruitment postcode(s) [1] 0 0
QLD 4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BellaSeno Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The clinical trial is testing the use of a novel method to grow new tissue within the breast
injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a
resorbable frame to support this growth of cells. The scaffold will be resorbed within at
least 3 years. The main assumption of this clinical trial is that the method used is safe and
effective for treatment of women requiring a silicone implant and /or correction of breast
defect and/or deformity. The other assumption is that this method is applicable to a wider
range of tissue defects, such as breast reconstruction after breast tissue removal. The new
method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination
of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue
regeneration using the natural healing processes in their body. This substance is resorbable
and is similar to the substance used for sutures and stitches that are dissolvable or
resorbable in the body. The substance used for the scaffold is already Therapeutic Goods
Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold
degrades over time, leaving the their own tissue in its place. The combination of scaffold
implantation and their own fat cells is the novel method in this trial. Conventional
liposuction techniques are used from another site on the patients body to harvest their fat
cells.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05437757
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Owen Ung
Address 0 0
Comprehensive Breast Cancer Institute (CBCI), Royal Brisbane and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries