~27 spots leftby Jan 2028

Autologous Fat-Based Therapy for Scar Tissue

Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByFrancesco Egro
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Pittsburgh
No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for individuals with severe burns or soft-tissue loss leading to contracted scars. Participants should have delayed wound healing, scar tissue complications, or need incision treatment. The study excludes those who don't meet specific health criteria set by the researchers.

Inclusion Criteria

I am seeking treatment for scar tightening that needs surgical correction.

Exclusion Criteria

I am under 18 years old.
I currently have an infection.
I have received radiation therapy to the area being studied.

Participant Groups

The study tests if fat grafting combined with split-thickness skin grafting (Autologous Layered Composite Grafting) can be as effective as full-thickness skin grafts in treating burn-related scarring and improving healing outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)Experimental Treatment1 Intervention
In this Arm, the investigators will assess Autologous Layered Composite Grafting for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a Autologous Layered Composite Graft.
Group II: Delayed Full Thickness Skin Graft (FTSG) ReconstructionActive Control1 Intervention
In this Arm, the investigators will assess FTSGs for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a FTSG.

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
Mercy HospitalPittsburgh, PA
Presbyterian HospitalPittsburgh, PA
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Who is running the clinical trial?

University of PittsburghLead Sponsor
Armed Forces Institute of Regenerative MedicineCollaborator

References