Autologous Point-of-Care Adipose Therapy: Recent Injury
Recruiting now · Not applicable
Conditions studied: Burns, Contracture Scar, Surgical Injury
In brief
The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive immediate fat grafting into the wound. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.
Key facts
- Study ID
- NCT06857448
- Run by
- University of Pittsburgh
- People needed
- 68
- Starts
- 2025-11-04
- Expected to finish
- 2028-10-30
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The proposed study will include adult patients 18 years of age or older,
- male or female,
- civilian, military, active duty or retired veterans
- presenting for unilateral or bilateral fasciotomy of the extremity at any level necessary
- secondary to non-infectious etiology,
- unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck or extremities necessitating reconstruction, and/or
- full or partial thickness burn injury of the face, neck, or extremity requiring excision and/or reconstruction.
- Additional inclusion criteria includes willingness to be randomized to receive a fat graft.
You may not qualify if…
- Age < 18 years of age,
- active infection,
- medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,
- unwilling or unable to comply with study procedures,
- radiation to the site of interest,
- prisoners and/or vulnerable populations.
- In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.
Where it is running
- Mercy Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- Presbyterian Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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