Veterans' facial wounds healed with Body's own fat in Two-Step procedure
NCT ID NCT06747715
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a two-step procedure to repair facial defects from injuries in veterans. First, doctors take fat from the patient and use it to fill the defect. Extra fat is frozen and used in a second procedure three months later, avoiding another fat harvest. The goal is to see if this approach safely improves facial appearance and tissue health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 3 and 150 cc of lipoaspirate (the patient's own fat, collected through liposuction). This may include patients who have not had craniofacial surgical procedures, as well as those who have undergone surgical procedures and have remaining deformities (post-surgical deformities). * Be at least 3 months post-injury or most recent surgery, so that acute edema (swelling) is resolved. * Volume defects (facial injury) are covered by intact skin and do not communicate with oral cavity or sinuses. * The three-dimensional geometry of the volume defects (facial injury) would allow for treatment with fat grafting. * Has sufficient donor tissue, as assessed on physical exam, to graft deformity and cryostore an equal amount of adipose (fat) tissue. * Willing and able to comply with follow up examinations, including radiographic studies (i.e. CT scans) 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: A second facial injury, that will not be treated by the study, that includes this type of defect, will not necessarily exclude the patient from participating). * Active infection anywhere in the body. * Systemic disease or medical condition that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient. * History of radiation to the areas intended for treatment or the graft harvest site * Medications that would significantly impact wound healing, such as immunosuppressive agents, chronic steroid treatment, or chemotherapy, or medications/allergies that would pose a risk to anesthesia or the planned procedures. * Active narcotic abuse (presents a variable for pain logs). * Known coagulopathy (increased risk of bleeding/delay in forming blood clots).
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As listed by the trial registrant
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How to take part
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
Locations
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15261, United States
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