Clinical trial NCT05003635: External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
Official title: External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: fat grafting
lipoaspirate
fat injection
fat transfer
lipofilling
liposculpturing
lipoinjection
lipotransfer
breast reconstruction
external pre-expansion
BRAVA
EVE
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2021-08-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 23-69
* BMI 18-35 - stable weight, no fluctuations
* Have undergone a total mastectomy at least 3 months prior the study, whether therapeutic or prophylactic, whether unilateral or bilateral, with no resection of the pectoralis muscle
* Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)
* Assessed by surgeon to have enough donor fat
* Passes a 20-minutes tolerance test with EVEBRA Device. (Patient will be fitted, instructed on the use, and given the EVEBRA Device to try in the office for 20 minutes. She passes if she tolerates its use, feels comfortable wearing it, and is able to comply with the required wear of the device.)

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 (acceptable to still be on aromatase inhibitors)
* except for the biopsy leading to the diagnosis of cancer, had surgery to breast prior to the mastectomy (e.g., multiple biopsies, implant augmentation, mastopexy, fat grating)
* had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection
* 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, as reported by patient
* known current substance abuse, as reported by patient
* history of silicone allergy, as reported by patient
* history of Gadolinium allergy, as reported by patient
* history of lidocaine allergy, as reported by patient
* bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarette smoker and/or Smokeless cigarette smokers, as reported by patient
* 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

Primary outcomes:
measure: Effectiveness measured in volume (MRI)
timeFrame: 1 year
Secondary outcomes:
measure: The quality of the reconstructed breast tissue as determined by MRI.
timeFrame: 12 months
measure: The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire
timeFrame: 12 months
measure: Return of sensation to the breast as determined by Semmes-Weinstein monofilaments (map of the reconstructed breast mound with record of sensory levels)
timeFrame: 12 months
measure: Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5.
timeFrame: 12 months
measure: Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line
timeFrame: 12 months
measure: Difference in bra cup size
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center (VUMC)
city: Hengelo
country: Netherlands
facility: Ziekenhuis groep Twente (ZGT)
Study officials:
affiliation: Maastricht University Medical Center
name: Andrzej Piatkowski de Gryzmala, MD, MsC
role: PRINCIPAL_INVESTIGATOR
References: