NCT02339779

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2015-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2015-01-15
• Last updated: 2022-02-21

Locations

7 sites across 1 country: Netherlands