Breast Augmentation Complications, Breast Implant Revision, Primary Breast Augmentation Surgery
Conditions
Keywords
Breast scaffold, PCL Scaffold, Absorbable Implant, Regenerative Medicine, Implant Removal, Breast Surgery, Clinical Safety and Performance, Primary Breast Augmentation
Brief summary
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation and breast augmentation revision surgery following previous breast implant insertion. The material (PCL) has been in clinical use for many decades and is absorbable. This study follows the successful completion of a 2-year evaluation of the safety and feasibility of this technique performed by the Royal Brisbane and Women's Hospital (ClinicalTrials.gov ID: NCT05437757). The main question it aims to answer is: "Is PCL Breast Scaffold with autologous fat graft a safe and effective method for soft tissue reconstruction following breast implant revision and for primary breast augmentation?". Participants will: * Undergo removal of their existing silicone breast implant (only for participants undergoing breast implant revision, if the implant has not been previously removed), * Receive implantation of a PCL Breast Scaffold combined with autologous fat grafting (AFG), and * Attend follow-up visits at 1 week, 3 months, 6 months, and annually for up to 5 years for clinical assessments and questionnaires.
Interventions
DEVICEImplantation of the PCL Breast scaffold with autologous fat grafting
The PCL Breast Scaffold is implanted in a pre-pectoral pocket immediately following removal of the silicone breast implant in participants undergoing breast implant revision. For participants whose implants have been previously removed, or those undergoing primary breast augmentation, a pre-pectoral pocket is created. The use of a submuscular placement may be allowed at discretion of the PI. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-case basis (e.g., Mastopexy,...). The PI will ensure accurate placement and secure fixation of the scaffold in the desired anatomical position. Autologous fat grafting (AFG) is then performed using fat cells harvested from the abdomen and/or thighs and injected into the implanted scaffold at the time of initial implantation. Then, wound closure and dressing will be conducted as per standard procedure. Sterile bandaging shall be initially applied and the wound reviewed daily whilst an inpatient.
Sponsors
BellaSeno Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a single-arm study. Participants are enrolled into two predefined cohorts: * Revision Augmentation Cohort: Women that previously received breast augmentation using a breast implant(s) and require breast implant augmentation revision surgery or have received breast implant explantation without replacement, meet the eligibility criteria and provide informed consent to participate in this study. * Primary Augmentation Cohort: Women undergoing their first breast procedure (no previous breast implants), meet the eligibility criteria and provide informed consent to participate in this study. All participants receive the same investigational device. The sample size is of 87 participants: 34 in the Revision Augmentation Cohort and 53 in the Primary Augmentation Cohort
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this clinical investigation, patients must meet ALL of the following criteria: 1. Genetically female 2. Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes 3. Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia) 4. Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study 5. Agree to not undergo any elective cosmetic surgery on her breasts for a minimum of 3 years following implantation of the investigational device Additional inclusion criteria applicable to the Revision Augmentation Cohort 6. Patients, age from 18 years old undergoing surgical revision of breast implants originally placed for cosmetic augmentation Additional inclusion criteria applicable to the Primary Augmentation Cohort: 6\. Patients, age from 18 years old undergoing primary augmentation surgery
Exclusion criteria
Patients may not participate in the clinical investigation if they meet ANY of the following criteria: 1. Based on the judgement of the Investigator, inadequate sites/ volume for harvesting the fat graft 2. Medical history of any malignant condition in the breast or chest wall region 3. Medical history of BRCA 1 or BRCA 2 Mutation 4. Abnormal findings on diagnostic imaging in the breast(s) intended for treatment within one year of study enrolment 5. Prior history of infection in the breast in the preceding 12 months 6. Prior surgery involving the breast in the preceding 12 months (except any previous removal of silicone implant) including autologous fat grafting. 7. Breast feeding in the preceding 12 months 8. Any local infection or rash within or close to the surgical fields (harvest site(s) or breasts) 9. Medical history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) 10. The patient has any disease, that is clinically known to impact wound healing ability 11. Known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency 12. Micro or macro angiopathia 13. Uncontrolled endocrine disorders 14. Clotting disorders, including thromboembolism 15. Known severe concurrent or intercurrent illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Investigator, compromise safety or compliance, or interfere with interpretation of study results 16. Polycaprolactone (PCL) allergy 17. Currently pregnant or breast feeding, or who are planning to become pregnant within 5 years after the breast surgery 18. Actively smoking or have a history of smoking (patient with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale) 19. Actively using recreational drugs or have a history of use of recreational drugs (patients with a history of use of recreational drugs may still be eligible pending assessment by investigating team and documentation of rationale) 20. Known allergies to MRI contrast agents 21. Unable or unwilling to comply with the treatment protocol 22. Unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment 23. Currently enrolled or has plans to enrol in another clinical study that would interfere with this study, unless it is retrospective or observational 24. Any patient condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes, or would preclude participation in the study Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs after index surgery within 12 months | Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery | Number of moderate and severe AEs with a probable or causal relationship to the device falling under pre-defined category over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast revision surgery rate | Assessed at post-surgery and at 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery | Number of breast revision surgeries categorized by reason and time |
| Rate and severity of all AEs related to device and/or procedure | Assessed at post-surgery, 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery | Number of AEs categorised by relationship with device and/or procedure (possible, probable, causal), severity and type over time |
| Total breast volume retention (3D Imaging) | Assessed at enrolment, surgery, and at 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-surgery | Total breast volume primarily assessed through 3D imaging. In case of immediate replacement, wight of the removed tissue and size of the removed silicone implant is also considered for total breast volume. Supportive data generated by: * Dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI); * Breast anthropomorphic measurements taken with tape measure or with Vectra imaging system (Sternal notch to nipple (SN-N), Nipple to Inframammary Fold (N-IMF), Overbust measurement, Underbust measurement, Chest circumference at highest projection); * Digital photos |
| Assessment of patient satisfaction, quality of life, body image, and psychological well-being using validated questionnaires (BREAST-Q) | Assessed at enrolment and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery | Patient-reported outcomes will be measured using the validated BREAST-Q questionnaire. The BREAST-Q Reconstruction module will be administered to participants of the Revision Augmentation Cohort, while the BREAST-Q Augmentation module will be administered to participants of the Primary Augmentation Cohort. Results are reported as a transformed score range from 0 to 100, with higher scores reflecting a better outcome. |
| Assessment of patient satisfaction, quality of life, body image, and psychological well-being using a 5-point Likert scale questionnaire | Assessed at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery | Patient-reported outcomes will be measured through a 5-point Likert scale questionnaire. Scores range from 1 to 5, with higher scores indicating better outcomes. |
| Assessment of surgical usability and surgeon satisfaction using a 5-point Likert scale questionnaire | Assessed at surgery and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery | The 5-point Likert scale questionnaire is administered to the PIs performing the surgical procedure. Scores range from 1 to 5, with higher scores indicating a better usability and greater surgeon satisfaction. |
Countries
Australia
Contacts
CONTACTProfessor Owen Ung
CONTACTProfessor Anand Deva
PRINCIPAL_INVESTIGATORProfessor Owen Ung
Royal Brisbane and Women's Hospital, Herston Biofabrication Institute
Outcome results
None listed