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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06857448). StuddyBuddy aggregates publicly available trial information.