Evaluation of the Clinical Evolution of Breast Increase Using Prostheses

NCT06079086 | Unknown DMC

• 1 other identifier: LIFESIL_001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Augmentation; Mammoplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Evaluate the long-term safety and effectiveness of prostheses (8-9 years)

  8-9 years

Study Arms (2)

Group A - group with textured envelope

ACTIVE COMPARATOR

Group A - group with textured envelope

Device: Breast Implants Lifesil

Group B - group with velvet/silicone foam envelope

ACTIVE COMPARATOR

Group B - group with velvet/silicone foam envelope

Device: Breast Implants Lifesil

Interventions

Breast Implants Lifesil DEVICE

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.

Group A - group with textured envelope; Group B - group with velvet/silicone foam envelope

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lifesil: lead

Study Officials

• Paulo Kharmandayan, PhD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: velvet/silicone foam envelope silicone with textured envelope

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 12, 2023
• Study Start: May 1, 2014
• Primary Completion: July 31, 2017
• Study Completion: May 30, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share