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External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
Sponsor: Maastricht University Medical Center
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.
Official title: External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
Key Details
Gender
FEMALE
Age Range
23 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2021-07-12
Completion Date
2026-10
Last Updated
2022-08-03
Healthy Volunteers
No
Conditions
Interventions
EVEBRA device
Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.
Locations (3)
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands
Amsterdam University Medical Center (VUMC)
Amsterdam, Netherlands
Ziekenhuis groep Twente (ZGT)
Hengelo, Netherlands