Breast Reconstruction, Mammaplasty, Mastectomy
Conditions
Brief summary
The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.
Interventions
DEVICEREVOLVE Advanced Adipose System
The REVOLVE system is an all-in-one fat processing device that harvests, filters, actively washes, and removes strands from lipoaspirate and allows for reinjection without any additional manipulation (REVOLVE 2020).
DEVICELipoGrafter
The LipoGrafter system is designed to be a start-to-finish closed system with minimal processing of the lipoaspirate, minimizing the risk of contamination and fat cell damage (LipoGrafter 2020).
PROCEDUREViality
The Viality system uses the AuraClens solution that acts as a surfactant to bring impurities like blood, free oil, and cellular debris into solution, where they can be flushed out through suction.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female; * Documented history of previous breast surgery (either complete or partial mastectomy); * Available harvest sites for fat grafting as documented by plastic surgeon; * BMI \> 20; * Anticipated harvested fat volume \> 50cc; * Competency and willingness to provide consent
Exclusion criteria
* Suspected or known to be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site | Baseline, 90 day follow-up | 3D volumetric scanning assesses the fat graft retention defined as the ratio of fat remaining at the surgical site at 90 day follow-up to that at pre-operative baseline. |
| Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire | Baseline, 90 day follow-up | The BREAST-Q questionnaire is used for measuring pre- and postoperative psychosocial, physical, and sexual well-being, satisfaction with breasts, experience of care, and satisfaction with outcome. Scores range on a 0-100 scale, with higher scores indicating better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of palpable masses from the fat grafting technique, as measured by a physical exam. | 90 day follow-up | The physical exam will provide the number of palpable masses at the surgical site. |
| Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam | 90 day follow-up | The physical exam will provide the number of lesions of probable fat necrosis at the surgical site |
| Presence of infection from the fat grafting technique, as measured by a physical exam | 90 day follow-up | The physical exam will show if there is infection present at the surgical site. This is a binary "yes/no" item. |
| Presence seroma from the fat grafting technique, as measured by a physical exam | 90 day follow-up | The physical exam will show if there is seroma present at the surgical site. This is a binary "yes/no" item. |
| Assessment of wound healing from the fat grafting technique, as measured by a physical exam | 90 day follow-up | The physical exam will show if wound healing is normal or delayed at the surgical site. This is a binary "normal/delayed" item. |
Countries
United States
Contacts
CONTACTMichael B Amrami, MPH
CONTACTDaana Bajnauth
PRINCIPAL_INVESTIGATORDavid Otterburn, MD
Weill Medical College of Cornell University
Outcome results
None listed