NCT06079086

Evaluation of the Clinical Evolution of Breast Increase Using Prostheses

Status unknown NA Last updated 12 October 2023

What this trial tests

NA trial testing Breast Implants Lifesil in Breast Augmentation in 60 participants. Status unknown.

Timeline

1 May 2014

Primary endpoint
31 July 2017

30 May 2024

Quick facts

Lead sponsor	Lifesil
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	60
Start date	1 May 2014
Primary completion	31 July 2017
Estimated completion	30 May 2024

Drugs / interventions tested

• Breast Implants Lifesil

Conditions studied

• Breast Augmentation — all drugs for Breast Augmentation →
• Mammoplasty — all drugs for Mammoplasty →

Sponsor

Lifesil

Who can join

18 and older, female only, with Breast Augmentation or Mammoplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.