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RECRUITING
NCT05003635
NA

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

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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

Interventions

DEVICE

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