External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
Maastricht University Medical Center
90 participants
Jul 12, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria16
- 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
Interventions
Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05003635