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

Mammoplasty Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502512
• Other study ID #: 2016-0463
• Secondary ID: NCI-2018-0094420
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: August 6, 2021

Study information

• Verified date: August 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mammoplasty Patient

Intervention

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Reconstructive Surgery
Undergo reconstructive surgery with REVOLVE technique
• Reconstructive Surgery
Undergo reconstructive surgery with PureGraft technique

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website