Autologous Fat Grafting Techniques in Patients Undergoing Reconstructive Surgery

July 11, 2020 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm I (RESOLVE 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.
Procedure: Autologous Fat Graft
Undergo AFG using the RESOLVE TM technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Autologous Fat Graft
Undergo AFG using the Cytori PureGraft TM technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Autologous Fat Graft
Undergo AFG using the Coleman technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Reconstructive Surgery
Undergo reconstructive surgery
Other Names:
  • Reconstruction
Arm II (Cytori PureGraft TM)
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.
Procedure: Autologous Fat Graft
Undergo AFG using the RESOLVE TM technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Autologous Fat Graft
Undergo AFG using the Cytori PureGraft TM technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Autologous Fat Graft
Undergo AFG using the Coleman technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Reconstructive Surgery
Undergo reconstructive surgery
Other Names:
  • Reconstruction
Arm III (Coleman technique)
Patients undergo AFG reconstructive surgery comprising standard centrifugation at 3200 rpm for 3 minutes with the resulting oil and aqueous layers discarded.
Procedure: Autologous Fat Graft
Undergo AFG using the RESOLVE TM technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Autologous Fat Graft
Undergo AFG using the Cytori PureGraft TM technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Autologous Fat Graft
Undergo AFG using the Coleman technique
Other Names:
  • Autologous Fat Cell Transplantation
  • Autologous Fat Injection
  • Autologous Fat Transfer
Procedure: Reconstructive Surgery
Undergo reconstructive surgery
Other Names:
  • Reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Summer Hanson, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2016

Primary Completion (Actual)

July 3, 2020

Study Completion (Actual)

July 3, 2020

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 11, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-0006 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2016-00346 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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