RecruitingNCT04261829

AFT: Introduction of a Full Breast Reconstructive Method

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

Sponsor

Maastricht University Medical Center

Enrollment

350 participants

Start Date

Dec 9, 2020

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Reconstructive Surgery Breast Reconstruction

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria15

Active smoker or a history of smoking 4 weeks prior to surgery
Current substance abuse
History of lidocaine allergy
History of silicone allergy
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

Interventions

PROCEDUREAutologous Fat Transfer

Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.