Status:
COMPLETED
Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
United States Department of Defense
Conditions:
Facial Injuries
Adipose Tissue
Eligibility:
All Genders
18+ years
Phase:
NA
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 te...
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...
Eligibility Criteria
Inclusion
- 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 lipaspirate in order to obtain symmetry.
- Willing and able to comply with follow up examinations, including radiographic studies
- Have completed participation in IRB# PRO09060101.
Exclusion
- 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
- Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
- Pregnancy
- 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.)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01822301
Start Date
April 1 2013
End Date
May 1 2015
Last Update
July 11 2017
Active Locations (1)
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1
Unversity of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213