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NCT06857448
Autologous Point-of-Care Adipose Therapy: Recent Injury
Conditions: Burns, Contracture Scar, Surgical Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 68
Sponsor: University of Pittsburgh
Location: Mercy Hospital Pittsburgh Pennsylvania
Summary
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.
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.
Source: ClinicalTrials.gov (NCT06857448). StuddyBuddy aggregates publicly available trial information.