Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 9:13 AM
Study NCT ID:
NCT02677012
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2016-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Randomized, Prospective Comparison of Time Associated With Techniques to Process Autologous Fat Grafts
Status:
COMPLETED
Status Verified Date:
2020-07
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 randomized clinical trial studies and compares 3 techniques in performing autologous fat grafting (AFG) in patients undergoing surgery to reshape or rebuild (reconstruct) a part of the body changed by previous surgery and inserted into another part of the body. AFG, also called fat injections or fat transplant, is a procedure in which an individual's own body fat (usually from abdomen or legs) is used during reconstructive surgery. Doctors want to compare 3 techniques for processing the fat tissue collected during surgery and the length of time needed to complete each AFG technique and surgery. Comparing 3 AFG techniques and the time to complete them during surgery may help doctors determine the best technique to perform fat grafting in the future.
Detailed Description:
PRIMARY OBJECTIVES:
I. Measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three aforementioned adipose tissue processing techniques.
SECONDARY OBJECTIVES:
I. To measure total fat grafting time: time from initiation of fat harvesting to the end of fat injection.
II. To measure volume of fat processed: volume of fat obtained after fat processing.
III. To measure total operation room (OR) time: time from patient entry into the OR (or when the patient barcode is read on entering the OR) to the time at which the patient leaves the OR.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (REVOLVE TM): Patients undergo AFG reconstructive surgery comprising washing and low velocity spinning using a commercially available system that washes the lipoaspirate with lactated Ringer's solution separates non-fat material from the fat with gentle centrifugal force and suction.
ARM II (CYTORI PUREGRAT TM): Patients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated Ringer's solution (RL) and the non-fat material is filtered through mesh.
ARM III (COLEMAN TECHNIQUE): Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 revolutions per minute (rpm) for 3 minutes with the resulting oil and aqueous layers discarded.
I. Measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three aforementioned adipose tissue processing techniques.
SECONDARY OBJECTIVES:
I. To measure total fat grafting time: time from initiation of fat harvesting to the end of fat injection.
II. To measure volume of fat processed: volume of fat obtained after fat processing.
III. To measure total operation room (OR) time: time from patient entry into the OR (or when the patient barcode is read on entering the OR) to the time at which the patient leaves the OR.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (REVOLVE TM): Patients undergo AFG reconstructive surgery comprising washing and low velocity spinning using a commercially available system that washes the lipoaspirate with lactated Ringer's solution separates non-fat material from the fat with gentle centrifugal force and suction.
ARM II (CYTORI PUREGRAT TM): Patients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated Ringer's solution (RL) and the non-fat material is filtered through mesh.
ARM III (COLEMAN TECHNIQUE): Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 revolutions per minute (rpm) for 3 minutes with the resulting oil and aqueous layers discarded.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-00346 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2015-0006 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |