AFT: Introduction of a Full Breast Reconstructive Method
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Female gender
Age of 18 years and older
History or in candidate for a mastectomy procedure in the near future
Patients undergoing preventive mastectomy
Disqualifiers
Active smoker or a history of smoking 4 weeks prior to surgery
Current substance abuse
History of lidocaine allergy
History of silicone allergy
Trial design
Treatments tested in this trial
- Autologous Fat Transfer
Treatment groups
350 Participants
are divided into 1 treatment groupSponsors and collaborators
Maastricht University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov