The purpose of this study is to compare fat graft retention over time from lipoaspirate processed using two FDA-cleared devices: the Revolve System (K120902) and the AuraGen 1-2-3 with AuraClens Lipoaspirate Wash System (BK190433).
This is a single-center, prospective, randomized study enrolling patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. A total of 20 patients will be enrolled in the study. Ten patients will receive lipoaspirate processed with the Revolve and ten patients will have lipoaspirate processed with the AuraGen 1-2-3 with AuraClens. Patients will be followed on post-procedure months 3, 6, and 12. Fat graft retention will be evaluated by photographic assessment by blinded reviewers, and 3D imaging. Patient satisfaction will be measured using the Breast-Q - Augmentation survey.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System
Back Bay Plastic Surgery
Boston, Massachusetts, United States
Fat volume retention at 3 months post-op
Measurement of volume of fat graft at 3 months post-op, using 3D photography
Time frame: 3 months post-op
Fat volume retention at 6 months post-op
Measurement of volume of fat graft at 6 months post-op, using 3D photography
Time frame: 6 months post-op
Fat volume retention at 12 months post-op
Measurement of volume of fat graft at 6 months post-op, using 3D photography
Time frame: 12 months post-op
Patient Satisfaction
Breast-Q - Augmentation Survey
Time frame: 3 months post-op
Patient Satisfaction
Breast-Q - Augmentation Survey
Time frame: 6 months post-op
Patient Satisfaction
Breast-Q - Augmentation Survey
Time frame: 12 months post-op
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