Not Yet RecruitingNot Applicable

Autologous Point-of-Care Adipose Therapy: Recent Injury

United States68 participantsStarted 2025-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total score on the Patient and Observer Scar Assessment Scale (POSAS): Pigmentation, Pliability, Vascularity, Thickness, Relief, and Surface Area, collected at the 9 month follow up visit.

Timeframe: From surgery to 9-month clinical endpoint.

Trial details

NCT IDNCT06857448

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

Contact for this trial

Eleanor Shirley

412-641-8676 shirleye@upmc.edu

View on ClinicalTrials.gov More Burns trials