External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

Recruiting now · Not applicable

Conditions studied: Breast Cancer Female

In brief

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.

Key facts

Study ID

NCT05003635

Run by

Maastricht University Medical Center

People needed

90

Starts

2021-07-12

Expected to finish

2026-10-01

Last updated by the study team

2022-08-03

Who can join

Age: 23 and older, up to 69. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (enrolling)
• Amsterdam University Medical Center (VUMC) — Amsterdam, Netherlands (enrolling)
• Ziekenhuis groep Twente (ZGT) — Hengelo, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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