External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery (EVE)

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Breast Cancer Female

Treatments: Device: EVEBRA device

Study type: Interventional

Funder types: Other

Identifiers

NCT05003635

METC20-099

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 23 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

AFT+ EVEBRA device (intervention arm)

Active Comparator group

Description:

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.

Treatment:

Device: EVEBRA device

AFT without EVEBRA device (control arm)

No Intervention group

Description:

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