Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT03502512
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Randomized, Prospective Comparison of Methods to Process Autologous Fat Grafts in Breast Reconstruction
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: