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

Not Applicable

Completed

• Conditions: Mammoplasty Patient
• Interventions: Other: Questionnaire Administration; Procedure: Reconstructive Surgery

• Registration Number: NCT03502512
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2018-02-13
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-18
• Status Verified: 2021-08
• Primary Completion: 2021-08-06
• Study Completion: 2021-08-06
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (REVOLVE technique)	Questionnaire Administration	Patients undergo reconstructive surgery with REVOLVE technique.
Arm II (PureGraft technique)	Reconstructive Surgery	Patients undergo reconstructive surgery with PureGraft technique.
Arm II (PureGraft technique)	Questionnaire Administration	Patients undergo reconstructive surgery with PureGraft technique.
Arm I (REVOLVE technique)	Reconstructive Surgery	Patients undergo reconstructive surgery with REVOLVE technique.

Primary Outcome Measures

Name	Time	Method
Fat graft retention rate	At 1 year	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States