Working… Menu

Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort (BTIPlusUp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01822301
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : May 12, 2017
Last Update Posted : July 11, 2017
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh

Brief Summary:

Fat grafting represents a technique with great potential to improve outcomes in minimally invasive facial reconstruction. Fat grafting has already been demonstrated as a safe and minimally invasive technique over decades of widespread practice in plastic surgery. In our current study of fat grafting for facial deformities (IRB# PRO09060101), we have treated 9 subjects without adverse event and all have had a significant improvement. Since all methods of treatment and evaluation are the same in this study, we will be able to use the data in our prior study as additional control data.

We hypothesize that repeating the fat grafting in subjects with previous facial fat grafts will enable successful restoration of tissue volume and craniofacial form. Additionally, we hypothesize that the results will be durable and subject quality of life improved.

Five (5) subjects (who were previously enrolled into IRB# PRO09060101) will be enrolled to this single center University of Pittsburgh site research study.

Condition or disease Intervention/treatment Phase
Facial Injuries Adipose Tissue Procedure: Repeat Fat grafting Not Applicable

Detailed Description:

Facial trauma injuries, especially those sustained in military combat and severe automobile crashes, are characterized by destruction of bone and soft tissue anatomy. While the bony skeleton can often be reconstructed, the overlying soft tissue is difficult to restore.

Importantly, it is the structure of the soft tissue that imparts the normal human form, and adequate reconstruction of soft tissue defects allows trauma victims to reintegrate into society. Accepted procedures for soft tissue reconstruction of the face involve tissue flap reconstruction procedures and autologous fat grafting. Tissue flap operations are extensive, often including microvascular surgery, and do not precisely correct the deformities. Fat grafting is a less invasive technique that allows for more precise shaping of the reconstructed tissues. However, autologous fat grafts may undergo resorption that can affect the appearance of the reconstruction over time. The degree of change in appearance after fat grafting has not been well studied for facial trauma patients.

We hypothesize that subjects who have successfully completed participation in the study (PRO09060101) and experienced graft resorbtion will have improved outcomes with an additional fat graft treatment. We anticipate that additional fat graft treatment will fully restore the facial features and overcome fat loss from the initial fat graft treatment. Additionally, we hypothesize that the cellular properties of the fat precursor cells (preadipocytes) may correlate with fat graft retention

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Repeat Facial fat grafting Procedure: Repeat Fat grafting
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 considered a standard of care procedure in plastic surgery. In brief, fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula in the operating room. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the facial deformity using specialized injection cannulas. In this study, we will treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) with be used for comparison.

Primary Outcome Measures :
  1. Facial Volume Score [ Time Frame: assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op ]
    the facial volume and appearance grading scale evaluates each aesthetic region in the face based on both physical examination and 3D photography by the clinician. scale ranges from 1-3 where a score of 1 indicates an obvious contour defect; 2 shows a noticeable improvement in contour but not sufficient to impart a normal appearance; 3 represents a normal appearance and/or close approximation with a normal uninjured contralateral structure.

Secondary Outcome Measures :
  1. Serial Computed Tomography Imaging [ Time Frame: assessed at 7-21 days, 3 months and 9 months post op. ]
    serial computed tomography images were collected to evaluate the volume of the defect

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged 18 years or older and able to provide informed consent
  2. Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 5 and 150 cc of lipoaspirate
  3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
  4. Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
  5. 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 lipaspirate in order to obtain symmetry.
  6. Willing and able to comply with follow up examinations, including radiographic studies
  7. Have completed participation in IRB# PRO09060101.

Exclusion Criteria:

  1. Age less than 18 years
  2. Inability to provide informed consent
  3. 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).
  4. Active infection anywhere in the body
  5. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
  6. Known coagulopathy
  7. Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
  8. Pregnancy
  9. Subjects with Schizophrenia, Bipolar Disorder. (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01822301

Layout table for location information
United States, Pennsylvania
Unversity of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
United States Department of Defense
Layout table for investigator information
Principal Investigator: Joseph P Rubin, MD University of Pittsburgh
Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM. The PTSD Checklist: Reliability, validity and diagnostic utility. Paper presented at the Annual Meeting of the International Society for Traumatic Stress Studies; 1993, San Antonio, TX.
Rosenberg, M. (1979). Conceiving the self. NY: Basic Books
Ware J, Kosinski M, Keller S. SF-36 Physical and mental heatlh summary scales: A users manual. 2nd ed. Boston: New England Medical Center, 1994
Lawrence J, Heinberg LJ, Roca A, Munster AM, Fauerbach JA. Development and validation of the Satisfaction with Appearance Scale: assessing body image among burn-injured patients. Psychological Assessment 1998; 10: 64-70.

Layout table for additonal information
Responsible Party: J. Peter Rubin, MD, Founding Chair Department of Plastic Surgery Professor of Surgery at the University of Pittsburgh School of Medicine, University of Pittsburgh Identifier: NCT01822301    
Other Study ID Numbers: PRO12100585
First Posted: April 2, 2013    Key Record Dates
Results First Posted: May 12, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is the Principal Investigator's intention to make stored samples and subject de-identified information available to secondary investigators after all research study testing has been completed. These stored samples and associated subject information will not include subject identifiers.
Keywords provided by J. Peter Rubin, MD, University of Pittsburgh:
Craniomaxillofacial (CMF) Battle-injured (BI)
Facial Trauma
Fat Grafts
Autogenous Fat Transfers (AFT)
Wounded warriors
Additional relevant MeSH terms:
Layout table for MeSH terms
Facial Injuries
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases