Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery

M.D. Anderson Cancer Center

Status: Completed

Conditions: Health Status Unknown

Treatments: Procedure: Reconstructive Surgery; Procedure: Autologous Fat Graft

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02677012

P30CA016672 (U.S. NIH Grant/Contract)

NCI-2016-00346 (Registry Identifier)

2015-0006 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with available harvest sites for fat grafting
• Patients with body mass index (BMI) > 20
• Estimated harvested fat volume >= 100 cc
• Patients are willing and able to give consent

Exclusion criteria

• Patients with active cancer, including primary cancer, recurrent cancer, or locally or distant metastasis
• Patients who are unable to provide consent
• Patients who are suspected or known to be pregnant

Trial design

50 participants in 3 patient groups

Arm I (RESOLVE TM)

Description:

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.

Treatment:

Procedure: Autologous Fat Graft

Procedure: Autologous Fat Graft

Procedure: Reconstructive Surgery

Procedure: Autologous Fat Graft

Arm II (Cytori PureGraft TM)

Description:

Patients undergo AFG reconstructive surgery comprising gravity filtration using a commercially available system in which the lipoaspirate is rinsed with lactated RL and the non-fat material is filtered through mesh.

Treatment:

Procedure: Autologous Fat Graft

Procedure: Autologous Fat Graft

Procedure: Reconstructive Surgery

Procedure: Autologous Fat Graft

Arm III (Coleman technique)

Description:

Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 rpm for 3 minutes with the resulting oil and aqueous layers discarded.

Treatment:

Procedure: Autologous Fat Graft

Procedure: Autologous Fat Graft

Procedure: Reconstructive Surgery

Procedure: Autologous Fat Graft