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Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer

2019-09-23 04:51:44 | BioPortfolio

Summary

The placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. It could also potentially improve the quality of life of patients

Description

Conservative surgery in breast cancer is performed more than 50% of cases, however, aesthetic results are suboptimal, because reconstructive techniques are performed in less than 5% of them. Objective: To demonstrate that the placement of a silicone prosthesis in partial defects generated by breast cancer conservative surgery improves the aesthetic result, compared to the usual surgical technique, safely, reproducibly and compatible with adjuvant treatments.

Methodology: Prospective randomized clinical trial, controlled with blind evaluator. Inclusion criteria: Women with breast cancer candidates for conservative surgery. Intervention: In the cases the study technique will be carried out consisting in the filling of the defect with a silicone prosthesis of size adjusted to it (2-4cm). Controls: usual surgical procedure. Main result variable: aesthetic results (visual analog scale) according to the patient, surgeon and blind external evaluator. Secondary variables: surgical complications, local complications derived from adjuvant treatments, rate of local recurrence, rate of reintervention due to affected margins, behavior in mammographic follow-up, professional satisfaction and impact on quality of life.

Study Design

Conditions

Breast Conserving Surgery

Intervention

Silicone prosthesis, Usual practice

Location

Hospital de la Santa Creu i Sant Pau
Barcelona
Spain
08041

Status

Recruiting

Source

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-23T04:51:44-0400

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Medical and Biotech [MESH] Definitions

Implants used to reconstruct and/or cosmetically enhance the female breast. They have an outer shell or envelope of silicone elastomer and are filled with either saline or silicone gel. The outer shell may be either smooth or textured.

Synthetic organosiloxane gels that are formed from synthetic polymers of silicone oxide with organic sidechains (polydimethylsiloxane) by lengthening the polymer chains. Unlike silicone elastomers, they are not treated with amorphous silica. They are used as fillers in breast implants.

A prosthetic appliance for the replacement of areas of the maxilla, mandible, and face, missing as a result of deformity, disease, injury, or surgery. When the prosthesis replaces portions of the mandible only, it is referred to as MANDIBULAR PROSTHESIS.

Surgical insertion of an inert sac filled with silicone or other material to augment the female form cosmetically.

Surgery performed in which part of the STAPES, a bone in the middle ear, is removed and a prosthesis is placed to help transmit sound between the middle ear and inner ear.

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