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ACTIVE NOT RECRUITING
NCT02339779
NA

Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

Summary

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.

Official title: the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2015-10

Completion Date

2026-10

Last Updated

2022-02-21

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

autologous fat transfer

Each procedure consists of the transfer of syringe-aspirated fat (form the abdomen, thighs, flanks) to the breast by injection in the subcutaneous planes. Typically three separate procedures are needed for a complete breast reconstruction: 1. First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes. 2. Second session is preceeded by wearing an external pre-expansion device to prepare the recipient site for grafting. It aims to give the breast its shape and initial volume. 3. Third session is also preceded by external pre-expansion and aims to provide extra volume of the breast to achieve symmetry with the healthy breast.

PROCEDURE

breast implant

Implant-based reconstruction typically will occur as follows: 1. During the primary mastectomy surgery, a tissue expander will be implanted subpectorally. 2. The tissue expander will be gradually filled with sterile saline during outpatient clinic visits. 3. When the desired volume is achieved, a second operation will be planned, to exchange the tissue expanded with the definite breast implant. (Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.)

Locations (7)

Amstelland Hospital

Amstelveen, Netherlands

VU Medical Center

Amsterdam, Netherlands

Alexander Monro Breast cancer hospital

Bilthoven, Netherlands

Amphia Hospital

Breda, Netherlands

Ziekenhuis Groep Twente Hospital

Hengelo, Netherlands

Maastricht University Medical Centre (MUMC+)

Maastricht, Netherlands

Bronovo-MCH Hospital

The Hague, Netherlands