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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFT+ EVEBRA device (intervention arm) | Active Comparator | 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. |
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| AFT without EVEBRA device (control arm) | No Intervention | Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVEBRA device | Device | Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness measured in volume (MRI) | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of the reconstructed breast tissue as determined by MRI. | Presence + description of necrotic cysts (Scale: amount of cyst and size in centimeters) | 12 months |
| The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maud Rijkx, MD, MsC | Contact | +31 (0) 43 38 723 08 | maud.rijkx@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Andrzej Piatkowski de Gryzmala, MD, MsC | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center+ | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
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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. |
| 12 months |
| Return of sensation to the breast as determined by Semmes-Weinstein monofilaments (map of the reconstructed breast mound with record of sensory levels) | 12 months |
| Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5. | 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. | 12 months |
| Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line | Difference noted in centimeters (cm) | 12 months |
| Difference in bra cup size | Cup size before and after reconstruction will be noted . | 12 months |
| Difference in Breast Volume 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. | Volume change will be noted in cubic centimetre(cc) | 12 months |
| Amsterdam University Medical Center (VUMC) | Recruiting | Amsterdam | Netherlands |
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| Ziekenhuis groep Twente (ZGT) | Recruiting | Hengelo | Netherlands |
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