Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About 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
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Full Thickness Skin Graft (FTSG)
- Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting).
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pittsburgh
Lead sponsor
Armed Forces Institute of Regenerative Medicine
Collaborator
Source ClinicalTrials.gov