Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06079086 |
Other study ID # |
LIFESIL_001 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2014 |
Est. completion date |
May 30, 2024 |
Study information
Verified date |
October 2023 |
Source |
Lifesil |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.