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

NAActive, not recruitingINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Breast Cancer
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.)"

Trial Locations (7)

Unknown

Amstelland Hospital, Amstelveen

VU Medical Center, Amsterdam

Alexander Monro Breast cancer hospital, Bilthoven

Amphia Hospital, Breda

Ziekenhuis Groep Twente Hospital, Hengelo

Bronovo-MCH Hospital, The Hague

6229HX

Maastricht University Medical Centre (MUMC+), Maastricht

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Maastricht University Medical Center

OTHER

NCT02339779 - Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy | Biotech Hunter | Biotech Hunter