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Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material

NCT02267187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-07-24

Study results available
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Summary

This study will examine the impact of the fat grafting procedure on facial appearance and quality of life over time by precisely measuring soft tissue volume with CT scans, assessing appearance with 2D and 3D photography and standard photography and evaluating quality of life through various validated psychosocial measures. This study will be a very important evaluation of the effectiveness of this therapy, and will help guide clinicians in applying this technique. Additionally, laboratory testing of the injected fat material will be performed so that the results may be correlated with clinical outcomes in the future.

The study endpoints include the analysis of the graft site via study procedures at different time points, the comparison of cotton rolling to centrifugation method of autologous fat grafting, as well as the correlation of cell behavior of the laboratory assays with clinical outcomes.

Conditions

  • Facial Injuries

Interventions

PROCEDURE

Fat Grafting

Fat Grafting is a procedure that involves moving a person's own fat from an area of the body where it is less needed to another area of the body to improve its appearance. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost volume or fullness due to aging, trauma, surgery, birth defects, or other causes.

DRUG

General Anesthesia

A medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure.

DEVICE

Coleman Cannulas

The plastic surgeon, will use small narrow tube-like instruments called cannulas, will remove fat from various places throughout the body (commonly the abdomen and thighs). The plastic surgeon will then use the Coleman cannulas (specialized smaller cannulas with varied shapes and tip sizes specifically made to deliver smaller amounts of fat) to fill the desired area.

OTHER

Tefla non-adherent gauze pad

The processing of the fat graft material is done using a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Joseph P Rubin, MD · Professor of Plastic Surgery at the University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-22
Primary Completion
2017-06-21
Completion
2017-06-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267187 on ClinicalTrials.gov