Breast AugmentationNCT06079086
Evaluation of the Clinical Evolution of Breast Increase Using Prostheses
A study testing Breast Implants Lifesil in people with Breast Augmentation and Mammoplasty, run by Lifesil.
Trial summary
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Mammoplasty
- What is being tested?
- Breast Implants Lifesil
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- who present complaints of hypomastia of different etiologies (constitutional hypotrophy, post-weight loss, post-breastfeeding
Who cannot join
- who have already had a prosthesis included before the clinical study and/or for prosthesis exchange
- with sequelae of mastectomy with loss of architecture of the breast region and requiring additional surgeries (flaps, grafts)
- with decompensated chronic disease
- pregnant or postpartum women
- minors, vulnerable with mental problems
- patients who have breast ptosis and require mastopexy
About this study
Official title: Evaluation of the Clinical Evolution of Breast Increase Using Prostheses With Textured Silicone Envelope and Prostheses With Silicone Velvet Envelope
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics. Breast augmentation surgery aims to add volume or restore breast volume lost post-pregnancy or weight loss, often establishing a balance in the body silhouette and increasing self-esteem. Breast implants cause an inflammatory reaction with the consequent formation of a fibrous capsule around the implant, which can evolve with different degrees of contraction.
Different factors are involved with the formation and intensity of the peri-prosthetic capsule: presence of hematoma, sub-clinical infection, silicone leakage, type of prosthetic envelope, plane/site of prosthesis placement, immune response, among others. The involvement of the envelope texture proved to be a major factor in reducing the formation of capsular contracture, which was clearly evident when covering with polyurethane foam was used. It is estimated that this reduction is due to the three-dimensional structure obtained with this configuration, which would result in a smaller vector resultant of contraction of the capsular fibers.
Read more
Aiming to obtain less capsular contracture, a silicone prosthesis with a velvet/silicone foam envelope was developed, which theoretically would have the advantage of the velvet/foam structure similar to polyurethane without, however, presenting negative aspects such as degradation, inflammation and eventual toxicity of catabolites. In this way, it is expected to prove the best postoperative evolution regarding the use of silicone prostheses with velvet/silicone foam coverage, highlighting the maintenance of the breast position over time. Furthermore, to intend to verify whether the velvet/silicone foam coverage determines a lower incidence of capsular contracture compared to the textured envelope. To this end, evaluation will be carried out through clinical examination and evaluation of digital photographic images taken pre-operatively, 30, 120, and 360 days post-operatively.
After a long postoperative period (approximately 9 years), a late follow-up will be carried out with the patients with clinical evaluation and a satisfaction questionnaire.
Read the detailed description
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics. Breast augmentation surgery aims to add volume or restore breast volume lost post-pregnancy or weight loss, often establishing a balance in the body silhouette and increasing self-esteem. Breast implants cause an inflammatory reaction with the consequent formation of a fibrous capsule around the implant, which can evolve with different degrees of contraction.
Different factors are involved with the formation and intensity of the peri-prosthetic capsule: presence of hematoma, sub-clinical infection, silicone leakage, type of prosthetic envelope, plane/site of prosthesis placement, immune response, among others. The involvement of the envelope texture proved to be a major factor in reducing the formation of capsular contracture, which was clearly evident when covering with polyurethane foam was used. It is estimated that this reduction is due to the three-dimensional structure obtained with this configuration, which would result in a smaller vector resultant of contraction of the capsular fibers.
Aiming to obtain less capsular contracture, a silicone prosthesis with a velvet/silicone foam envelope was developed, which theoretically would have the advantage of the velvet/foam structure similar to polyurethane without, however, presenting negative aspects such as degradation, inflammation and eventual toxicity of catabolites. In this way, it is expected to prove the best postoperative evolution regarding the use of silicone prostheses with velvet/silicone foam coverage, highlighting the maintenance of the breast position over time. Furthermore, to intend to verify whether the velvet/silicone foam coverage determines a lower incidence of capsular contracture compared to the textured envelope. To this end, evaluation will be carried out through clinical examination and evaluation of digital photographic images taken pre-operatively, 30, 120 and 360 days post-operatively.
After a long postoperative period (approximately 9 years), a late follow-up will be carried out with the patients with clinical evaluation and a satisfaction questionnaire.
It is expected to demonstrate better postoperative evolution when using silicone prostheses with velvet/silicone foam coverage, highlighting the maintenance of position and less capsular contracture. To evaluate the participants' satisfaction with the silicone prosthesis after a prolonged post-operative period, through a satisfaction questionnaire, where the questions will be applied in a face-to-face consultation with the study doctor, who will also evaluate the participants' clinical conditions. Data will be obtained to evaluate the safety and efficacy of the implant over the long term of implantation.
- Conditions
- Breast Augmentation, Mammoplasty
- Being tested
- Breast Implants Lifesil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Implants LifesilDevice
The surgery is performed through an incision (4 cm) in the inframammary fold and displacement in the supra-muscular plane, creation of a pocket for the inclusion of the prosthesis, followed by strict hemostasis and washing with an antibiotic solution. Placement of the prosthesis by digital maneuver and closure in layers using absorbable synthetic 4-0 polycaprolactone suture. Afterwards, an occlusive dressing is applied to the surgical wound. IV antibiotics (cephalosporin) 1g are administered at the beginning of surgery, followed by repeat/booster doses every 6 hours in the first 24 hours. Analgesic and anti-inflammatory medications are administered, varying according to each patient's restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Group A - group with textured envelope | Active comparator | Group A - group with textured envelope Receives: Device: Breast Implants Lifesil |
| Group B - group with velvet/silicone foam envelope | Active comparator | Group B - group with velvet/silicone foam envelope Receives: Device: Breast Implants Lifesil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Evaluate the possible occurrence of capsular contracture, maintenance of the position of the prosthesis and shape of the breasts postoperatively at 30, 120 and 360 days. Through clinical examination and standardized photographic documentation.
Measured: 1 year
Secondary outcomes (1)
Evaluate the long-term safety and effectiveness of prostheses (8-9 years)
To evaluate the safety and effectiveness of prostheses in the long term (8-9 years), through a questionnaire applied in a clinical consultation, with a late post-operative follow-up
Measured: 8-9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 May 2014
- Primary completion31 Jul 2017
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- velvet/silicone foam envelope silicone with textured envelope
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifesil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paulo Kharmandayan, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079086
- Sponsor's protocol ID
- LIFESIL_001
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Evolution of Breast Increase Using Prostheses With Textured Silicone Envelope and Prostheses With Silicone Velvet Envelope
- ClinicalTrials.gov ID
- NCT06079086
- Acronym / sponsor ID
- LIFESIL_001
- Conditions
- Breast Augmentation, Mammoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LifesilIndustry (pharma, biotech, devices)
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics. Breast augmentation surgery aims to add volume or restore breast volume lost post-pregnancy or weight loss, often establishing a balance in the body silhouette and increasing self-esteem. Breast implants cause an inflammatory reaction with the consequent formation of a fibrous capsule around the implant, which can evolve with different degrees of contraction.
Different factors are involved with the formation and intensity of the peri-prosthetic capsule: presence of hematoma, sub-clinical infection, silicone leakage, type of prosthetic envelope, plane/site of prosthesis placement, immune response, among others. The involvement of the envelope texture proved to be a major factor in reducing the formation of capsular contracture, which was clearly evident when covering with polyurethane foam was used. It is estimated that this reduction is due to the three-dimensional structure obtained with this configuration, which would result in a smaller vector resultant of contraction of the capsular fibers.
Aiming to obtain less capsular contracture, a silicone prosthesis with a velvet/silicone foam envelope was developed, which theoretically would have the advantage of the velvet/foam structure similar to polyurethane without, however, presenting negative aspects such as degradation, inflammation and eventual toxicity of catabolites. In this way, it is expected to prove the best postoperative evolution regarding the use of silicone prostheses with velvet/silicone foam coverage, highlighting the maintenance of the breast position over time. Furthermore, to intend to verify whether the velvet/silicone foam coverage determines a lower incidence of capsular contracture compared to the textured envelope. To this end, evaluation will be carried out through clinical examination and evaluation of digital photographic images taken pre-operatively, 30, 120, and 360 days post-operatively.
After a long postoperative period (approximately 9 years), a late follow-up will be carried out with the patients with clinical evaluation and a satisfaction questionnaire.
Detailed description
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics. Breast augmentation surgery aims to add volume or restore breast volume lost post-pregnancy or weight loss, often establishing a balance in the body silhouette and increasing self-esteem. Breast implants cause an inflammatory reaction with the consequent formation of a fibrous capsule around the implant, which can evolve with different degrees of contraction.
Different factors are involved with the formation and intensity of the peri-prosthetic capsule: presence of hematoma, sub-clinical infection, silicone leakage, type of prosthetic envelope, plane/site of prosthesis placement, immune response, among others. The involvement of the envelope texture proved to be a major factor in reducing the formation of capsular contracture, which was clearly evident when covering with polyurethane foam was used. It is estimated that this reduction is due to the three-dimensional structure obtained with this configuration, which would result in a smaller vector resultant of contraction of the capsular fibers.
Aiming to obtain less capsular contracture, a silicone prosthesis with a velvet/silicone foam envelope was developed, which theoretically would have the advantage of the velvet/foam structure similar to polyurethane without, however, presenting negative aspects such as degradation, inflammation and eventual toxicity of catabolites. In this way, it is expected to prove the best postoperative evolution regarding the use of silicone prostheses with velvet/silicone foam coverage, highlighting the maintenance of the breast position over time. Furthermore, to intend to verify whether the velvet/silicone foam coverage determines a lower incidence of capsular contracture compared to the textured envelope. To this end, evaluation will be carried out through clinical examination and evaluation of digital photographic images taken pre-operatively, 30, 120 and 360 days post-operatively.
After a long postoperative period (approximately 9 years), a late follow-up will be carried out with the patients with clinical evaluation and a satisfaction questionnaire.
It is expected to demonstrate better postoperative evolution when using silicone prostheses with velvet/silicone foam coverage, highlighting the maintenance of position and less capsular contracture. To evaluate the participants' satisfaction with the silicone prosthesis after a prolonged post-operative period, through a satisfaction questionnaire, where the questions will be applied in a face-to-face consultation with the study doctor, who will also evaluate the participants' clinical conditions. Data will be obtained to evaluate the safety and efficacy of the implant over the long term of implantation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- velvet/silicone foam envelope silicone with textured envelope
| Arm | Type | Receives |
|---|---|---|
| Group A - group with textured envelope | Active comparator | Device: Breast Implants LifesilGroup A - group with textured envelope |
| Group B - group with velvet/silicone foam envelope | Active comparator | Device: Breast Implants LifesilGroup B - group with velvet/silicone foam envelope |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- who present complaints of hypomastia of different etiologies (constitutional hypotrophy, post-weight loss, post-breastfeeding
Key exclusion criteria (6 listed)
- who have already had a prosthesis included before the clinical study and/or for prosthesis exchange
- with sequelae of mastectomy with loss of architecture of the breast region and requiring additional surgeries (flaps, grafts)
- with decompensated chronic disease
- pregnant or postpartum women
- minors, vulnerable with mental problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Implants LifesilThe surgery is performed through an incision (4 cm) in the inframammary fold and displacement in the supra-muscular plane, creation of a pocket for the inclusion of the prosthesis, followed by strict hemostasis and washing with an antibiotic solution. Placement of the prosthesis by digital maneuver and closure in layers using absorbable synthetic 4-0 polycaprolactone suture. Afterwards, an occlusive dressing is applied to the surgical wound. IV antibiotics (cephalosporin) 1g are administered at the beginning of surgery, followed by repeat/booster doses every 6 hours in the first 24 hours. Analgesic and anti-inflammatory medications are administered, varying according to each patient's restrictions. | Device | Group A - group with textured envelope, Group B - group with velvet/silicone foam envelope |
Primary outcome
Incidence of Adverse Events
Time frame: 1 year
Evaluate the possible occurrence of capsular contracture, maintenance of the position of the prosthesis and shape of the breasts postoperatively at 30, 120 and 360 days. Through clinical examination and standardized photographic documentation.
1 secondary outcome
Evaluate the long-term safety and effectiveness of prostheses (8-9 years)
Time frame: 8-9 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Kharmandayan, PhD principal investigator
University of Campinas, Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Breast Implants Lifesil in people with Breast Augmentation and Mammoplasty, run by Lifesil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.