NCT02677012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

4.4 years

First QC Date

February 4, 2016

Last Update Submit

July 11, 2020

Conditions

Health Status Unknown

Outcome Measures

Primary Outcomes (1)

  • Rate of fat processed defined as the volume of fat harvested per minute

    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

Study Arms (3)

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 GraftProcedure: Reconstructive Surgery

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 GraftProcedure: Reconstructive Surgery

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 GraftProcedure: Reconstructive Surgery

Interventions

Autologous Fat GraftPROCEDURE

Undergo AFG using the RESOLVE TM technique

Also known as: Autologous Fat Cell Transplantation, Autologous Fat Injection, Autologous Fat Transfer
Arm I (RESOLVE TM)
Reconstructive SurgeryPROCEDURE

Undergo reconstructive surgery

Also known as: Reconstruction
Arm I (RESOLVE TM)Arm II (Cytori PureGraft TM)Arm III (Coleman technique)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Hanson SE, Garvey PB, Chang EI, Reece GP, Liu J, Baumann DP, Butler CE. A Randomized Prospective Time and Motion Comparison of Techniques to Process Autologous Fat Grafts. Plast Reconstr Surg. 2021 May 1;147(5):1035-1044. doi: 10.1097/PRS.0000000000007827.

    PMID: 33890883DERIVED

Related Links

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Summer Hanson

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 9, 2016

Study Start

February 4, 2016

Primary Completion

July 3, 2020

Study Completion

July 3, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

US(1)