Clinical trial NCT06079086: Evaluation of the Clinical Evolution of Breast Increase Using Prostheses
Official title: Evaluation of the Clinical Evolution of Breast Increase Using Prostheses With Textured Silicone Envelope and Prostheses With Silicone Velvet Envelope
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Augmentation
Mammoplasty
Lead sponsor: Lifesil
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: velvet/silicone foam envelope silicone with textured envelope
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* who present complaints of hypomastia of different etiologies (constitutional hypotrophy, post-weight loss, post-breastfeeding

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the long-term safety and effectiveness of prostheses (8-9 years)
timeFrame: 8-9 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Campinas, Brazil
name: Paulo Kharmandayan, PhD
role: PRINCIPAL_INVESTIGATOR
References: