REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction

Study Overview
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Brief Summary
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This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be processed (sometimes referred to as washed or prepared) before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.

Detailed Description
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PRIMARY OBJECTIVES: I. To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques. SECONDARY OBJECTIVES: I. To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma. II. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry. III. To measure patient reported outcomes (PRO, BREAST-Questionnaire [Q], Body Image Survey). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo reconstructive surgery with REVOLVE technique. ARM II: Patients undergo reconstructive surgery with PureGraft technique. After completion of study, patients are followed up at 2-4 weeks and then once a year for up to 2 years.

Official Title
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A Randomized, Prospective Comparison of Methods to Process Autologous Fat Grafts in Breast Reconstruction

Conditions
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Mammoplasty Patient

Intervention / Treatment
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* Other: Questionnaire Administration
* Procedure: Reconstructive Surgery
* Procedure: Reconstructive Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous breast surgery, either mastectomy or partial mastectomy Patients with available harvest sites for fat grafting Patients with body mass index (BMI) > 20 Anticipated harvested fat volume > 100 cc Patients are willing and able to give consent Exclusion Criteria: Patients with active cancer, including primary cancer, recurrent cancer and locally or distantly metastatic cancer Patients who are unable to provide consent Patients who are 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (REVOLVE technique)<br>Patients undergo reconstructive surgery with REVOLVE technique. | Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Reconstructive Surgery<br>* Undergo reconstructive surgery with REVOLVE technique<br>* Other names: Reconstruction;|
| Experimental: Arm II (PureGraft technique)<br>Patients undergo reconstructive surgery with PureGraft technique. | Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Reconstructive Surgery<br>* Undergo reconstructive surgery with PureGraft technique<br>* Other names: Reconstruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat graft retention rate | Rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of the REVOLVE and PureGraft tissue processing techniques. | At 1 year |