STEPS S: Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface

Sponsor
Silimed Industria de Implantes Ltda (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05345821
Collaborator
Centro Universitário Saúde ABC (Other)
384
1
147
2.6

Study Details

Study Description

Brief Summary

The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    384 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2034
    Anticipated Study Completion Date :
    Dec 1, 2034

    Arms and Interventions

    Arm Intervention/Treatment
    primary augmentation group

    Women undergoing primary breast augmentation with Silimed® smooth surface Breast Implant.

    secondary (revision) augmentation group

    Women undergoing secundary or revision breast augmentation with Silimed® smooth surface Breast Implant.

    Outcome Measures

    Primary Outcome Measures

    1. Expected Adverse Events [Every three years over the 10-year duration of the study]

      Estimate the known short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®

    2. Unexpected Adverse Events [Every three years over the 10-year duration of the study]

      Estimate the unknown short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®

    Secondary Outcome Measures

    1. Patient's Satisfaction in Relation to Aesthetic Result [Every three years over the 10-year duration of the study]

      Estimate the performance of Silimed® breast implant with smooth surface through the satisfaction of the patient regarding the aesthetic result after breast augmentation. The assessment of patient's satisfaction will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely satisfied, 2 = satisfied, 3 = slightly satisfied, 4 = slightly dissatisfied and 5 = definitely unsatisfied.

    2. Patient's Satisfaction in General [Every three years over the 10-year duration of the study]

      Estimate the performance of Silimed® breast implants with smooth surface after breast augmentation by means of a questionnaire, the Breast Self-Assessment Questionnaire (BEQ-Brazil), which consist of 55 questions related to satisfaction and comfort with the overall appearance of the breasts.

    3. Evaluator's Satisfaction in Relation to Aesthetic Result [Every three years over the 10-year duration of the study]

      Estimate the performance of Silimed® breast implant with smooth surface througt the satisfaction of the evaluator regarding the aesthetic result after patient's breast augmentation. The assessment of evaluator's satisfaction will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely satisfied, 2 /= satisfied, 3= slightly satisfied, 4 = slightly dissatisfied and 5 = definitely unsatisfied.

    4. Patient's Quality of Life [Every three years over the 10-year duration of the study]

      Estimate the performance of Silimed® breast implant with smooth surface through the quality of life of the patient after breast augmentation. The assessment of patient's quality of life will be done by means of the Rosemberg Global Self-Esteem Scale, in order to evaluate the overall self-esteem of the sample.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Provide written informed consent

    • Female at birth

    • Be 18 years of age or older

    • Have a complaint of hypomastia

    • Have an indication for breast augmentation with silicone implants

    • Ability to comply with the protocol throughout the follow-up period.

    Exclusion Criteria:
    • Replacement of breast implants due to a complication

    • Breast reconstruction in at least one breast

    • Informed pregnancy or breastfeeding at the time of inclusion

    • Sequelae of mastopexy

    • Ptosis

    • Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms

    • Advanced fibrocystic disease at the time of implantation

    • Neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - Active infection not yet treated or undergoing treatment at any site at the time of implantation

    • Report or record of adverse reactions or intolerance to silicone prior to implantation

    • Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation

    • Signs of inflammation of the breast or implant site at the time of implantation

    • Increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use

    • Having participated in another clinical trial within 6 months prior to implant placement

    • Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundação do ABC - Centro universitário FMABC Santo André São Paulo Brazil 09060-870

    Sponsors and Collaborators

    • Silimed Industria de Implantes Ltda
    • Centro Universitário Saúde ABC

    Investigators

    • Principal Investigator: André Luiz P de Freitas, Fundação do ABC - Centro Universitário FMABC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Silimed Industria de Implantes Ltda
    ClinicalTrials.gov Identifier:
    NCT05345821
    Other Study ID Numbers:
    • 6001022
    First Posted:
    Apr 26, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Silimed Industria de Implantes Ltda

    Study Results

    No Results Posted as of Jul 28, 2022