Breast Reconstruction
Conditions
Keywords
post-market, safety, performance, breast reconstruction, acellular matrix
Brief summary
The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction. The safety of the acellular matriz will be evaluated by estimating known and unexpected adverse event rates assessed by clinical evaluations and patient reports of adverse events after implantation in addition to monitoring integration by Magnetic Resonance Imaging (MRI). The performance of Silimed® brand acellular matriz will be evaluated by clinical effectiveness of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Secondary performance outcomes include: assessment of body image-related quality of life, self-esteem assessment, aesthetic and functional breast assessment, and participant satisfaction level.
Interventions
DEVICEAcellular matrix
Silimed® brand acellular matrix
Sponsors
Silimed Industria de Implantes Ltda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent; * Female sex at birth; * Be 18 years of age or older; * Have an indication for reconstructive surgeries requiring reinforcement, repair, regeneration, and reconstruction of tissues in the breast region; * Have well-vascularized tissue, according to the physician's clinical assessment, for better cell infiltration, revascularization, and incorporation; * Have an indication for breast reconstruction with Silimed acellular matrix intended for subcutaneous or submuscular implantation; * Have an indication for breast reconstruction with Silimed breast implants; * Have the ability to comply with the protocol for the entire follow-up period.
Exclusion criteria
* Breast augmentation without reconstruction in at least one breast; * Neoplasia of any type that is not yet treated, or is under treatment, or requires surgical removal at the time of implantation\*; * Pregnancy or breastfeeding at the time of implantation; * Smoking, uncontrolled diabetes, obesity (grade 2 or higher) or ASA (American Society of Anesthesiology) pre-surgical classification III/IV (ANNEX I); * Active infection that is not yet treated or is under treatment at any site at the time of implantation; * Active inflammation that is not yet treated or is under treatment at the implantation site; * Report or record of adverse reactions or intolerance or known history of hypersensitivity to collagen or bovine products at the time of implantation; * Report or record of adverse reactions or intolerance to silicone; * Any immune disorder or disease at the time of implantation; * Depressed immune system at the time of implantation; * Report or record of atopy at the time of implantation; * Record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (e.g., medications that interfere with coagulation); * High surgical risk or risk of complications in the immediate post-surgical period estimated before implantation; * Evidence or report of tissue characteristics that are clinically incompatible with successful implantation (e.g., tissues with excessive fibrosis or compromised vascularization); * Having participated in another clinical study up to 6 months before matrix placement, unless the investigator judges it to be beneficial for the participant and not impacting the study; * Any other condition that, based on the opinion of the investigator or designated individual, may prevent the provision of informed consent, make participation in the study unsafe, compromise adherence to the protocol, complicate the interpretation of outcome data, or otherwise interfere with the achievement of the study objectives. * Breast neoplasia where part of the treatment involves an initial surgical approach does not constitute an exclusion criterion, provided that this treatment decision is reported and that the patient is followed by an oncologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of the combination of acellular matrix + Silimed® brand breast implants. | From enrollment to the end of study at 18 months | To estimate the risk and rate of expected and unexpected adverse events from the combination of acellular matrix + Silimed® brand breast implants |
| Performance of the combination of acellular matrix + Silimed® brand breast implants. | From surgery to the end of study at 18 months | Evaluation of the clinical efficacy of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Acellular Matrix is indicated for the reinforcement, repair, regeneration, and reconstruction of breast tissue in reconstructive surgeries. Its adequate integration into the recipient tissue is an essential parameter of the expected clinical performance, as it enables the incorporation of the material into the surgical bed and the success of the reconstructive process. Matrix integration will be evaluated by magnetic resonance imaging in approximately one-third of the study population. It should be noted that the degree and time of integration may vary between patients, influenced by individual factors such as biological characteristics, inflammatory response, and local. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluator's Satisfaction | From surgery to the end of study at 18 months | Satisfaction with the aesthetic outcome will be assessed at all planned in-person follow-up visits. A Likert scale will be used to measure satisfaction, with the following options available: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, and 5 = definitely satisfied. In the case of responses 1 and 2, the reasons for dissatisfaction will be collected for a qualitative analysis of the conditions that determine the dissatisfaction. |
| Participant's Satisfaction | From surgery to the end of study at 18 months | Satisfaction with the aesthetic outcome will be assessed at all planned in-person follow-up visits. A Likert scale will be used to measure satisfaction, with the following options available: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, and 5 = definitely satisfied. In the case of responses 1 and 2, the reasons for dissatisfaction will be collected for a qualitative analysis of the conditions that determine the dissatisfaction. |
| Patient's Quality of Life | From enrollment to the end of study at 18 months | The assessment of patient's self-esteem will be done by means of the Rosemberg Global Self-Esteem Scale, in order to evaluate the overall self-esteem of the sample. Also, the Breast Evaluation Questionnaire will be filled by them to assess breast satisfaction and changes in quality of life. |
| Assessment of body image | From enrollment to the end of study at 18 months | For the assessment of body image in the sample of this study, the Hopwood Body Image Scale (BIS) will be used. This instrument is a scale developed specifically for assessing body image as a dimension of quality of life. |
Countries
Brazil
Contacts
CONTACTRenata R M Figueira
CONTACTMaria Clara Sodré
PRINCIPAL_INVESTIGATORMarcelo A Belo
Hospital de câncer - HCIII (INCA)
Outcome results
None listed