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

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

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.

Study Overview

• Status: Completed
• Conditions: Mammoplasty Patient
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Reconstructive Surgery; Procedure: Reconstructive Surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Gregory Reece, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2016-0463 (Other Identifier: M D Anderson Cancer Center); NCI-2018-00944 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No