Skip to main content
OpenTrials
Completed

NCT Number: NCT02677012

Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Fat Graft

Procedure

Undergo AFG using the RESOLVE TM technique

Other names: Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat Transfer

Reconstructive Surgery

Procedure

Undergo reconstructive surgery

Other names: Reconstruction

Primary outcomes

  1. Rate of fat processed defined as the volume of fat harvested per minute

    Time frame: 1 day

    Study data will be collected and managed using the Research Electronic Data Capture. This study will measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three adipose tissue processing techniques.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Randomized, Prospective Comparison of Time Associated With Techniques to Process Autologous Fat Grafts

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 9, 2016
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.