Trial Outcomes & Findings for Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material (NCT NCT02267187)

NCT ID: NCT02267187

Last Updated: 2018-07-24

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Assessed at 7-21 days, 3 months, 9 months

Results posted on

2018-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Cotton Rolling Fat Grafting 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 Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Cotton Rolling Fat Grafting 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 Study Physician Decision	2
Overall Study Screen fail	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cotton Rolling Fat Grafting n=10 Participants 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.
Age, Continuous	46.2 years STANDARD_DEVIATION 13.3 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	10 Participants n=99 Participants

PRIMARY outcome

Timeframe: Assessed at 7-21 days, 3 months, 9 months

Outcome measures

Outcome measures
Measure	Cotton Rolling Fat Grafting n=10 Participants 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.
Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. 7-21 days	11.4 milliliters Standard Deviation 6.6
Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. 3 months	7.4 milliliters Standard Deviation 4.9
Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. 9 months	6.5 milliliters Standard Deviation 4.7

PRIMARY outcome

Timeframe: screen, 7-21 days, 3, and 9 months post-operative

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.

Outcome measures

Outcome measures
Measure	Cotton Rolling Fat Grafting n=10 Participants 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.
Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. screen	1.0 units on FVAS scale Standard Deviation 0.0
Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. 7-21 days	2.6 units on FVAS scale Standard Deviation 0.5
Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. 3 months	2.2 units on FVAS scale Standard Deviation 0.4
Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative. 9 months	2.2 units on FVAS scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Assessed at time of operative procedure

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.

Outcome measures

Outcome measures
Measure	Cotton Rolling Fat Grafting n=10 Participants 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.
Assessment of Cellular Properties of the Cells Within the Fat Graft	27.9 percentage of ASCs within the SVF Standard Deviation 17.7

Adverse Events

Cotton Rolling Fat Grafting

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cotton Rolling Fat Grafting n=10 participants at risk 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.
Surgical and medical procedures Bruising	100.0% 10/10 • Number of events 10 • 7-21 days, 3 months, 9 months post-operatively.

Additional Information

Patsy Simon

University of Pittsburgh

Phone: 412-648-9207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place