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

NCT03502512 | Completed

• 2 other identifiers: 2016-0463NCI-2018-00944
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammoplasty Patient

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I (REVOLVE technique)

EXPERIMENTAL

Patients undergo reconstructive surgery with REVOLVE technique.

Other: Questionnaire Administration; Procedure: Reconstructive Surgery

Arm II (PureGraft technique)

EXPERIMENTAL

Patients undergo reconstructive surgery with PureGraft technique.

Other: Questionnaire Administration; Procedure: Reconstructive Surgery

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (REVOLVE technique); Arm II (PureGraft technique)

Reconstructive Surgery PROCEDURE

Undergo reconstructive surgery with REVOLVE technique

Also known as: Reconstruction

Arm I (REVOLVE technique)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Gregory Reece, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 18, 2018
• Study Start: February 13, 2018
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (1)