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

NCT02339779 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2022-02-21

No results posted yet for this study

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.

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.)

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Andrzej Piatkowski de Grzymala, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339779 on ClinicalTrials.gov