A Comparative Analysis of REVOLVE, LipoGrafter, and the Standard Decantation Technique in Autologous Fat Grafting During Breast Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Analysis of REVOLVE, LipoGrafter, and the Standard Decantation Technique in Autologous Fat Grafting During Breast Surgery

Conditions
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Mastectomy, Mammaplasty, Breast Reconstruction

Intervention / Treatment
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* Device: REVOLVE Advanced Adipose System
* Device: LipoGrafter
* Procedure: Standard Decantation technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: REVOLVE Advanced Adipose System<br>Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction. | Device: REVOLVE Advanced Adipose System<br>* 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).<br>|
| Active Comparator: LipoGrafter<br>Participants will receive the LipoGrafter technique during breast reconstruction. | Device: LipoGrafter<br>* 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).<br>|
| Active Comparator: Standard Decantation<br>Participants will receive the Standard decantation technique during breast reconstruction. | Procedure: Standard Decantation technique<br>* Traditional standard decantation technique for breast reconstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |