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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous fat transfer reconstruction

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

Group Type EXPERIMENTAL

autologous fat transfer

Intervention Type PROCEDURE

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.

Reconstruction with breast implants

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

Group Type ACTIVE_COMPARATOR

breast implant

Intervention Type PROCEDURE

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.)

Interventions

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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.

Intervention Type 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.)

Intervention Type PROCEDURE

Other Intervention Names

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lipofilling fat grafting lipografting lipoaspirate grafting autologous fat injection breast prosthesis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No