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

Maastricht University Medical Centre (MUMC)

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: breast implant; Procedure: autologous fat transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT02339779

METC142059

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female gender
• Age of 18 years and older
• History or in candidate for a mastectomy procedure in the near future
• Patients' choice to undergo a breast reconstruction
• Wanting to participate in this study
• Patient is able to wear the BRAVA device

Exclusion criteria

• Active smoker or a history of smoking 4 weeks prior to surgery
• Current substance abuse
• History of lidocaine allergy
• History of silicone allergy
• 4 weeks or less after chemotherapy
• History of radiation therapy in the breast region
• Oncological treatment includes radiotherapy after mastectomy
• Kidney disease
• Steroid dependent asthma (daily or weekly) or other diseases
• Immune-suppressed or compromised disease
• Uncontrolled diabetes
• BMI>30
• Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
• Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
• The treating plastic surgeon has strong doubts on the patient's treatment compliance
• Claustrophobia for an MRI-scan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Autologous fat transfer reconstruction

Experimental group

Description:

Breast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast.

Treatment:

Procedure: autologous fat transfer

Reconstruction with breast implants

Active Comparator group

Description:

Control group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander.

Treatment:

Procedure: breast implant