Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Before and after the AFT surgery, patients are required to wear the EVEBRA expansion device for a total duration of 4 weeks. Thereafter patients will receive a PexyBra over the reconstructed breast.

Pre-operatively patients are required to wear the device for a total of 200 hours.

Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device.

Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.

EVEBRA device

Maud Rijkx, MD, MsC

Andrzej Piatkowski, MD, PhD

Jan Maerten Smit, MD, MsC

Ute Schmidbauer, MD, PhD

Andrzej Piatkowski de Gryzmala, MD, MsC

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 with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery

All women will have an MRI for Baseline Breast Volume measurement at the time of enrollment. Final breast volume will be also determined by MRI 6 months after the first grafting procedure (AFT#1).

The primary effectiveness endpoint is the Percentage Augmentation of the mastectomy defect at 12 months after AFT#1.

Presence + description of necrotic cysts (Scale: amount of cyst and size in centimeters)

Qscore will be used to assess final scores. As described in the BREAST-Q Module, summed scores will be converted into a score from 0 (worst) to 100 (best) per domain. Higher scores reflect a better outcome.

The aesthetic improvement will be rated using pre-operative and one year post-operative 2D images by a group of experts, breast cancer patients and age-matched male and female laymen. All parties rate the pre-/post- 3D images on a Likert scale (5 points) with one indicating no improvement and 5 indicating perfect improvement.

Cup size before and after reconstruction will be noted .

Volume change will be noted in cubic centimetre(cc)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery	NCT05003635	Breast Cancer F...	EVEBRA device	23 Years - 69 Years	Maastricht University Medical Center
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery	NCT05003635	Breast Cancer F...	EVEBRA device	23 Years - 69 Years	Maastricht University Medical Center

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