breast reconstruction breast reconstructive surgery
Conditions
Interventions
EVEBRA group: Subjects randomized into the EVEBRA group will receive the EVEBRA
Device.
Control group: The control subjects will receive a conventional AFT breast
reconstruction, without the use of
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Female gender - Age of 18 years and older - History or in candidate for a mastectomy procedure in the near future - Patients undergoing preventive mastectomy - Patients* choice to undergo a breast reconstruction - Wanting to participate in this study - Patient is able to wear the external expansion device
Exclusion criteria
Exclusion criteria: • untreated breast cancer • history of radiation therapy on the involved breast, even if it was part of a previous breast conservation procedure • completed chemotherapy course less than 2 months prior • except for the biopsy leading to the diagnosis of cancer, had surgery to breast prior to the mastectomy • had mastectomy wound healing complications • mastectomy defect/scar has significant skin excess and deep folds adherent to the chest wall • has a pacemaker or aneurysm clips • pregnancy or breastfeeding • had a cardiac stent placed within the last 2 months • claustrophobic • known current substance abuse • history of silicone allergy • history of Gadolinium allergy • history of lidocaine allergy • bleeding diathesis, whether primary or iatrogenic • cigarette smoker and/or Smokeless cigarette smokers • medical conditions that preclude breast reconstruction including uncontrolled hypertension or diabetes, renal failure, steroid dependent asthma, and on immuno- suppressant medications, as reported by patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 12 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The quality of the reconstructed breast tissue as determined by MRI. (Presence of necrotic cysts, their size and number) - The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire - Return of sensation to the breast as determined by Semmes-Weinstein monofilaments (map of the reconstructed breast mound with record of sensory levels) - Visual/standard photographic appearance of the reconstructed breast - Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line - Difference in bra cup size - Difference in Breast Volume Increase from the randomization baseline after the three sessions of fat grafting (Final Reconstructed Breast Volumes) as measured by the validated Vectra 3D imaging system and the MRI. | — |
Countries
Netherlands
Outcome results
None listed