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Recruiting NCT06857435

Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

Conditions: Burns, Contracture Scar, Surgical Injury

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
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 contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture? 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 fat grafting at time of scar revision. * 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 scar contracture release and reconstruction at any level. * 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 (NCT06857435). StuddyBuddy aggregates publicly available trial information.