AFT: Introduction of a Full Breast Reconstructive Method
Recruiting now
Conditions studied: Breast Cancer, Reconstructive Surgery, Breast Reconstruction
In brief
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.
Key facts
- Study ID
- NCT04261829
- Run by
- Maastricht University Medical Center
- People needed
- 350
- Starts
- 2020-12-09
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2021-07-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Viecuri Venlo — Venlo, Limburg, Netherlands (enrolling)
- Ziekenhuis groep Twente (ZGT) — Hengelo, Netherlands (enrolling)
- Medical Center Leeuwarden — Leeuwarden, Netherlands (enrolling)
- Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands
- Amphia — Breda, Netherlands
- Alexander Monro, Bilthoven — Bilthoven, Netherlands
- Amsterdam University Medical Center (VUMC) — Amsterdam, Netherlands
- Rijnstate — Arnhem, Netherlands
Full record on ClinicalTrials.gov
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