Autologous layered fat-and-skin grafting for post-burn scar contracture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with burn or trauma-related scar contractures are randomized to receive either standard full-thickness skin grafting or an autologous layered composite grafting approach that includes a fat graft at the base followed by skin grafting. The study aims to determine non-inferiority of the fat-plus-skin method in healing, scar quality, and infection risk. Evaluators are blinded to treatment assignment to reduce bias. The approach is designed as a single-stage reconstruction to improve tissue softness, reduce scarring, and simplify the procedure. Primary methods include fat grafting at the time of scar revision and concurrent split-thickness skin grafting for soft-tissue restoration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mercy Hospital
  Pittsburgh, Pennsylvania, United States Recruiting
• Presbyterian Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Francesco Egro — University of Pittsburgh
• Study coordinator: Eleanor Shirley
• Email: shirleye@upmc.edu
• Phone: 412-641-8676

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.