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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REVOLVE Advanced Adipose System | Active Comparator | Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction. |
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| LipoGrafter | Active Comparator | Participants will receive the LipoGrafter technique during breast reconstruction. |
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| Viality | Active Comparator | Participants will receive the Viality technique during breast reconstruction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REVOLVE Advanced Adipose System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site | 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. | Baseline, 90 day follow-up |
| Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire | 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. | Baseline, 90 day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of palpable masses from the fat grafting technique, as measured by a physical exam. | The physical exam will provide the number of palpable masses at the surgical site. | 90 day follow-up |
| Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Amrami, MPH | Contact | 646-544-7658 | mia7046@med.cornell.edu | |
| Daana Bajnauth | Contact | 646-789-1447 | dab4001@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Otterburn, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian - Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
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| LipoGrafter | Device | 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). |
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| Viality | Procedure | 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. |
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The physical exam will provide the number of lesions of probable fat necrosis at the surgical site |
| 90 day follow-up |
| Presence of infection from the fat grafting technique, as measured by a physical exam | The physical exam will show if there is infection present at the surgical site. This is a binary "yes/no" item. | 90 day follow-up |
| Presence seroma from the fat grafting technique, as measured by a physical exam | The physical exam will show if there is seroma present at the surgical site. This is a binary "yes/no" item. | 90 day follow-up |
| Assessment of wound healing from the fat grafting technique, as measured by a physical exam | The physical exam will show if wound healing is normal or delayed at the surgical site. This is a binary "normal/delayed" item. | 90 day follow-up |