Autologous Point-of-Care Adipose Therapy: Recent Injury
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 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.
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 unilateral or bilateral fasciotomy of the extremity at any level necessary
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
- Split Thickness Skin Graft (STSG)
- Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pittsburgh
Lead sponsor
Armed Forces Institute of Regenerative Medicine
Collaborator
Source ClinicalTrials.gov