AFT: Introduction of a Full Breast Reconstructive Method
Recruiting · NCT04261829 · Observational (researchers observe without assigning treatment) · Lead sponsor: Maastricht University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Autologous Fat Transfer
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
8 locations listed.
- 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
- Maastricht University Medical Center+ - Maastricht, Limburg, Netherlands
- Viecuri Venlo - Venlo, Limburg, Netherlands