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โ† Trials
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AFT: Introduction of a Full Breast Reconstructive Method

Recruitingn/aAges 18 Years - anyFemaleMaastricht University Medical Center
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In plain words

What the trial is, and whether it could suit you

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female gender * Age of 18 years and older * History or in candidate for a mastectomy procedure in the near future * Patients undergoing preventive mastectomy * Patients' choice to undergo a breast reconstruction * Wanting to participate in this study * Patient is able to wear the external expansion device Exclusion Criteria: * Active smoker or a history of smoking 4 weeks prior to surgery * Current substance abuse * History of lidocaine allergy * History of silicone allergy * 4 weeks or less after chemotherapy * History of radiation therapy in the breast region * Oncological treatment includes radiotherapy after mastectomy * Kidney disease * Steroid dependent asthma (daily or weekly) or other diseases * Immune-suppressed or compromised disease * Uncontrolled diabetes * BMI\>30 * Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C * Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction * The treating plastic surgeon has strong doubts on the patient's treatment compliance
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What it tests

  • Autologous Fat Transfer
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Where

8 sites
Maastricht University Medical Center+
Maastricht, Netherlands
Viecuri Venlo
Venlo, Netherlands
Amsterdam University Medical Center (VUMC)
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Alexander Monro, Bilthoven
Bilthoven, Netherlands
Amphia
Breda, Netherlands
Ziekenhuis groep Twente (ZGT)
Hengelo, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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