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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Mammoplasty Patient

Treatments: Procedure: Reconstructive Surgery; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03502512

NCI-2018-00944 (Registry Identifier)

2016-0463

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Arm I (REVOLVE technique)

Experimental group

Description:

Patients undergo reconstructive surgery with REVOLVE technique.

Treatment:

Other: Questionnaire Administration

Procedure: Reconstructive Surgery

Arm II (PureGraft technique)

Experimental group

Description:

Patients undergo reconstructive surgery with PureGraft technique.

Treatment:

Other: Questionnaire Administration

Procedure: Reconstructive Surgery