Breast Tissue Expander, Safety and Performance
Conditions
Keywords
post-market, safety, performance, Breast tissue expander, breast reconstruction
Brief summary
The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction. The safety of the breast tissue expander will be evaluated by estimating known and unexpected adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand breast tissue expander will be evaluated by evaluating the assessment of tissue quality and satisfaction by the evaluating physician after implantation.
Interventions
DEVICEBreast tissue expander
Silimed brand breast tissue expander
Sponsors
Silimed Industria de Implantes Ltda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. provide written informed consent 2. female sex at birth; 3. be 18 years of age or older; 4. have an indication for reconstruction with breast expander + breast implant(s); 5. have a plan to receive an expander with a textured surface from the Silimed® brand + implant breast with textured surface from the Silimed® brand; 6. ability to comply with the protocol throughout the follow-up period.
Exclusion criteria
1. breast augmentation without reconstruction in at least one breast; 2. neoplasia of any type (except breast neoplasia), not yet treated or under treatment, or requiring surgical removal at the time of implantation; 3. pregnancy or breastfeeding at the time of implantation; 4. smoking, uncontrolled diabetes, obesity (from grade 2) and ASA III/IV; 5. active infection not yet treated or being treated at any site at the time of implantation; 6. report or record of adverse reactions or intolerance to silicone prior to implantation; 7. immune diseases that affect connective tissue in activity or under treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation; 8. record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (eg, medications that interfere with coagulation); 9. high surgical risk or complications in the immediate post-surgery period, estimated before the implantation; 10. evidence or report of tissue characteristics that are clinically inconsistent with a successful implantation (eg tissues with excessive fibrosis or compromised vascularization); 11. may not have participated in another clinical study up to 6 months before placement of the expander, unless the researcher deems it to be good for the participant and not impact the study; 12. previous treatment with radiotherapy; 13. any other condition that, based on the opinion of the researcher or designee, may prevent the provision of informed consent, make study participation unsafe, compromise adherence to the protocol, complicate the interpretation of study outcome data or otherwise interfere with the achievement of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Through study completion, an average of 1 year | Estimate adverse events rate for breast tissue expander |
| Evaluator's Satisfaction in Relation to expansion | Through study completion, an average of 1 year | Estimate the performance of Silimed® brand breast tissue expander with through the satisfaction of the evaluator (investigator) regarding the result of the expansion so far. The assessment will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely unsatisfied, 2 = unsatisfied, 3 = slightly satisfied, 4 = satisfied and 5 = definitely satisfied. |
| Evaluator's Assessment of tissue quality | Through study completion, an average of 1 year | The assessment of tissue quality is clinical and will occur at every visit, including the final assessment. Estimate the performance of Silimed® brand breast tissue expander with textured surface throught the satisfaction of the evaluator regarding the vascularization, innervation, color and texture of and quality of the expanded tissue. To measure satisfaction, a Likert scale where the following satisfaction options can be marked: 1 = definitely dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied and 5 = definitely satisfied. Satisfaction will be measured in percentages of each category of the Likert scale in each follow-up time. Values from 0 to 20 will be considered poor results, bad results from 21 to 40, intermediate results from 41 to 60, good results from 61 to 80, and excellent results from 81 to 100. |
Countries
Brazil
Contacts
CONTACTRenata R M Figueira
CONTACTLudmila C Donato
PRINCIPAL_INVESTIGATORMarcelo A Bello
Hospital de câncer - HCIII (INCA)
Outcome results
None listed