N/A
N=20
A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury
Facial Injuries · Adipose Tissue
Bottom Line
View on ClinicalTrials.gov: NCT01345591 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Volume — 0.576; 0.621 milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fat Grafting (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume |
0.576; 0.621 | — |
| SECONDARY SWAP, COPE and CSQ-8 |
59.7; 57.8; 57.9; 56.3; 57.1; 56.8 | — |
Summary
Injuries resulting in facial trauma are common, and can have devastating consequences on your quality of life. While the facial bones can often be reconstructed, physicians strive to find better ways to accurately restore injured facial features.
In this clinical trial funded by the Department of Defense, the investigators are evaluating how effectively fat grafting can restore facial features, and how the filling effect of the fat graft lasts over time in participants with visible facial injuries. All procedures for this research study will be performed at the University of Pittsburgh Medical Center.
Eligibility 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 lipoaspirate 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 -
Data sourced from ClinicalTrials.gov (NCT01345591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.