NCT06857435 Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
| NCT ID | NCT06857435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-11-04 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Francesco Egro
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06857435 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06857435 currently recruiting?
Yes, NCT06857435 is actively recruiting participants. Contact the research team at shirleye@upmc.edu for enrollment information.
Where is the NCT06857435 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Pittsburgh, United States.
Who is sponsoring the NCT06857435 clinical trial?
NCT06857435 is sponsored by University of Pittsburgh. The principal investigator is Francesco Egro at University of Pittsburgh. The trial plans to enroll 40 participants.