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Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material (BTI++)

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ClinicalTrials.gov Identifier: NCT02267187
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : May 17, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Facial Injuries
Interventions Procedure: Fat Grafting
Drug: General Anesthesia
Device: Coleman Cannulas
Other: Tefla non-adherent gauze pad
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cotton Rolling Fat Grafting
Hide Arm/Group Description

For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.

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

Period Title: Overall Study
Started 15
Completed 10
Not Completed 5
Reason Not Completed
Physician Decision             2
Screen fail             3
Arm/Group Title Cotton Rolling Fat Grafting
Hide Arm/Group Description

For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.

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

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
46.2  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.
Hide Description [Not Specified]
Time Frame Assessed at 7-21 days, 3 months, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cotton Rolling Fat Grafting
Hide Arm/Group Description:

For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.

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

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: milliliters
7-21 days 11.4  (6.6)
3 months 7.4  (4.9)
9 months 6.5  (4.7)
2.Primary Outcome
Title Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative.
Hide Description Facial volume appearance is based on the established Facial Volume Appearance Scale (FVAS). The scale is from 1-3 where 1 indicates no improvement and 3 indicates noticeable improvement of facial volume appearance.
Time Frame screen, 7-21 days, 3, and 9 months post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cotton Rolling Fat Grafting
Hide Arm/Group Description:

For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.

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

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on FVAS scale
screen 1.0  (0.0)
7-21 days 2.6  (0.5)
3 months 2.2  (0.4)
9 months 2.2  (0.4)
3.Secondary Outcome
Title Assessment of Cellular Properties of the Cells Within the Fat Graft
Hide Description Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft.
Time Frame Assessed at time of operative procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cotton Rolling Fat Grafting
Hide Arm/Group Description:

For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.

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

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of ASCs within the SVF
27.9  (17.7)
Time Frame 7-21 days, 3 months, 9 months post-operatively.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cotton Rolling Fat Grafting
Hide Arm/Group Description

For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is known as a filler providing an accurate means to restoring facial soft tissue structure.

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

All-Cause Mortality
Cotton Rolling Fat Grafting
Affected / at Risk (%)
Total   0/10 (0.00%)    
Hide Serious Adverse Events
Cotton Rolling Fat Grafting
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cotton Rolling Fat Grafting
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Surgical and medical procedures   
Bruising   10/10 (100.00%)  10
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Patsy Simon
Organization: University of Pittsburgh
Phone: 412-648-9207
EMail: simonpa@upmc.edu
Layout table for additonal information
Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02267187    
Other Study ID Numbers: PRO14040197
First Submitted: August 8, 2014
First Posted: October 17, 2014
Results First Submitted: April 18, 2018
Results First Posted: May 17, 2018
Last Update Posted: July 24, 2018