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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02267187
First received: August 8, 2014
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Facial Injuries
Procedure: Fat Grafting
Drug: General Anesthesia
Device: Coleman Cannulas
Other: Tefla non-adherent gauze pad

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Evaluation of the changes in facial appearance over time in craniofacial trauma patients who have been treated with autologous fat grafting. [ Time Frame: as assessed 7-21 days, 3 months and 9 months ] [ Designated as safety issue: No ]
    This study will examine the impact of the fat grafting procedure on facial appearance by precisely measuring soft tissue volume with CT scans

  • Evaluation of the changes in facial appearance over time in craniofacial trauma patients who have been treated with autologous fat grafting. [ Time Frame: as assessed 7-21 days, 3 months and 9 months ] [ Designated as safety issue: No ]
    Evaluation using photography (both 2-D and 3-D images)


Secondary Outcome Measures:
  • Assessment of facial appearance and soft tissue volume before and after autologous fat grafting using CT scans, standard photography and 3D photography. [ Time Frame: Assessed at screening, 7-21 days, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Assessment of cellular properties of the cells within the fat graft [ Time Frame: Assessed at time of operative procedure ] [ Designated as safety issue: No ]
    Properties will be assessed using the following measures: Preadipocyte yield, Preadipocyte Viability, Preadipocyte Proliferation and Preadipocyte characterization.

  • Measure of quality of life in patients before and after autologous fat grafting using validated psychosocial measures. [ Time Frame: Assessed at screening, 3 months and 9 months ] [ Designated as safety issue: No ]
    This will be assessed using standard validated Quality of Life Questionnaires.

  • Assessment of Safety [ Time Frame: Assessed opeartive procedure,3-6 days, 7-21 days, 3 months, 9 months ] [ Designated as safety issue: Yes ]
    Number of Participants experiencing adverse events


Estimated Enrollment: 10
Study Start Date: August 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fat Graftting
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.
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.

Detailed Description:

Clinical use of autologous fat grafting in humans was described as early as 1893, when Neuber published his report of transferring multiple small particles of fat to fill a soft tissue depression. Over the past three decades, autologous fat grafting has become a common procedure in clinical plastic surgery, and is also employed by clinicians in other specialties. The refinement of liposuction techniques in the 1980's made it possible to harvest the adipose grafts with low risk and without the need for a significant incision. The liposuction aspirate could simply be reinjected at a different site. Specialized equipment has been developed for fat grafting and is commercially available from a number of sources. The American Society of Plastic Surgeons 2007 procedural statistics show that over 65,000 fat grafting procedures were performed in the United States (www.plasticsurgery.org) during the previous year.

Fat grafting may represent a superior method of facial reconstruction after severe trauma, but the results can be impacted by resorption of fat volume over time. The specific aims of the study are:

  1. Assess facial appearance and soft tissue volume before and after autologous fat grafting using CT scans and 3D photography.
  2. Assess cellular properties of the cells within the fat graft
  3. Comparison of cotton rolling to centrifugation method of autologous fat grafting
  4. Measure of quality of life in patients before and after autologous fat grafting using validated psychosocial measures.

Ten (10) subjects 18 years of age and older will be enrolled to this trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or older and able to provide informed consent
  • Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 5 and 150 cc of lipoaspirate
  • Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
  • Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
  • The three dimensional geometry of the volume defects would allow for treatment with lipoaspirate injection that in a manner that at least two distinct treated areas could be discerned on gross examination and radiographically (e.g. treated regions are on opposite sides of the face, on lower face versus upper face, or separated by a bony landmark such as zygoma. This would include the ability to treat an uninjured contralateral region with lipospirate in order to obtain symmetry.
  • Willing and able to comply with follow up examinations, including radiographic studies

Exclusion Criteria:

  • Age less than 18 years
  • Inability to provide informed consent
  • Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: presence of such a defect in the setting of another defect(s) that meets treatment criteria will not exclude the patient from participating)
  • Active infection anywhere in the body
  • Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
  • Known coagulopathy
  • Pregnancy
  • Subjects with an Axis I to diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable (as defined by the screening Psychosocial assessment) could be eligible for study participation per the Physician's discretion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02267187

Contacts
Contact: Mara A Yerk 412-864-2587

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: CIRM    412-864-2587      
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J Peter Rubin, MD Professor of Plastic Surgery at the University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02267187     History of Changes
Other Study ID Numbers: PRO14040197
Study First Received: August 8, 2014
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Craniomaxillofacial (CMF)
Battle-injured (BI)
Facial Trauma
Fat Grafts
Autogenous Fat Transfers (AFT)
Wounded Warriors

Additional relevant MeSH terms:
Facial Injuries
Craniocerebral Trauma
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014