Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants (STEPS A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356132
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Silimed Industria de Implantes Ltda

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.

Condition or disease Intervention/treatment
Breast Implant; Complications Quality of Life Satisfaction Device: Silimed® Textured Silicone Gel-Filled Breast Implant Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1052 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : July 2033
Estimated Study Completion Date : December 2034

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Textured Group
Women undergoing primary and secondary breast augmentation with Silimed® Textured Silicone Gel-Filled Breast Implant.
 Device: Silimed® Textured Silicone Gel-Filled Breast Implant
Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
Polyurethane Group
Women undergoing primary and secondary breast augmentation with Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
 Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Expected Adverse Events [ Time Frame: Annually through the 10 years length of the study. ]
    Estimate the known short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface

  2. Unexpected Adverse Events [ Time Frame: Annually through the 10 years length of the study. ]
    Estimate the unknown short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface


Secondary Outcome Measures :
  1. Patient's Satisfaction in Relation to Aesthetic Result [ Time Frame: Annually through the 10 years length of the study. ]
    Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered 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 [ Time Frame: Annually through the 10 years length of the study. ]
    Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered 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 [ Time Frame: Annually through the 10 years length of the study. ]
    Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface through 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 [ Time Frame: Annually through the 10 years length of the study. ]
    Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women aged 18 years old or older who have undergone breast augmentation using Silimed® silicone gel-filled breast implants with textured surface or Silimed® silicone gel-filled breast implants with polyurethane foam coated surface.
Criteria

Inclusion Criteria:

  • women aged 18 years or older,
  • who had received breast implant(s) up to 21 days prior because of the need for primary or secondary breast augmentation,
  • ability to comply with the protocol for the entire follow-up time,
  • have received Silimed® textured breast implants or polyurethane foam coated surface breast implants,
  • provide free and informed consent.

Exclusion Criteria:

  • mammary reconstruction in at least one breast or augmentation after previous reconstruction,
  • pregnancy informed or breastfeeding at the inclusion moment,
  • advanced fibrocystic disease at the time of implantation,
  • neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
  • reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
  • immune diseases affecting active connective tissue or (eg, 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 immediate postoperative complications due to use of illicit drugs or medications,
  • have participated in another clinical study up to 6 months prior to the placement of the implant,
  • any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356132


Contacts
Layout table for location contacts
Contact: Ludmila Donato +552198399-0573 pesquisaclinica@silimed.com.br
Contact: Mariana Couto +55213687-7000 mariana.couto@silimed.com.br

Locations
Layout table for location information
Brazil
Perfektua Serviços Médicos Ltda Recruiting
Niterói, Rio De Janeiro, Brazil, 24230-052
Contact: Celso EJ Boechat, MD    +55 21 99624-2604    ceboechat@gmail.com   
Principal Investigator: Celso EJ Boechat, MD         
Sponsors and Collaborators
Silimed Industria de Implantes Ltda
Investigators
Layout table for investigator information
Principal Investigator: Celso EJ Boechat, MD Perfektua Serviços Médicos Ltda
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Silimed Industria de Implantes Ltda
ClinicalTrials.gov Identifier: NCT03356132    
Other Study ID Numbers: 6002030
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The IPD will be shared starting 6 months after the end of the study.
Access Criteria: It was not defined yet.

Layout table for additional information
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:
breast implant
complication
satisfaction
quality of life
 augmentation
textured
polyurethane