Autologous Point-of-Care Adipose Therapy: Recent Injury
Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Recent Injury
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
About the study
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.
What is being tested
- Split Thickness Skin Graft (STSG) (procedure)
- Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). (procedure)
Sponsor: University of Pittsburgh · Participants: 68 · Started: Nov 4, 2025
Contact the study team
- Eleanor Shirley · Phone: 412-641-8676
- Patsy Simon · Phone: 412-641-8676
Official record on ClinicalTrials.gov — NCT06857448
Locations in the U.S.
| Pennsylvania | Mercy Hospital, Pittsburgh Presbyterian Hospital, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.