Evaluation of the Clinical Evolution of Breast Increase Using Prostheses

NAActive, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 1, 2014

Primary Completion Date

July 31, 2017

Study Completion Date

May 30, 2024

Conditions
Breast AugmentationMammoplasty
Interventions
DEVICE

Breast Implants Lifesil

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lifesil

INDUSTRY

NCT06079086 - Evaluation of the Clinical Evolution of Breast Increase Using Prostheses | Biotech Hunter | Biotech Hunter