Autologous Point-of-Care Adipose Therapy: Recent Injury
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Split Thickness Skin Graft (STSG)
Procedure/SurgeryPartial thickness skin in STSGs are performed by harvesting via dermatome the donor site. Donor sites are typically taken from a flat surface on the thigh, lower back, or gluteal region to allow for a graft of even thickness and the selection of donor site is to be based on clinical standard practice. These grafts are placed on the prepared recipient site.
Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
Procedure/SurgeryAutologous Layered Composite Grafting consists of the layered strategy of simultaneous fat and skin grafting. Fat is harvested by minimally invasive liposuction and applied directly to the wound base without any chemical or biologic processing. Skin is harvested as a split thickness skin graft by dermatome and applied over the layer of adipose tissue.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Acute Split Thickness Skin Graft (STSG) ReconstructionActive comparator 1 intervention
Group B: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total score on the Patient and Observer Scar Assessment Scale (POSAS): Pigmentation, Pliability, Vascularity, Thickness, Relief, and Surface Area, collected at the 9 month follow up visit.
POSAS measures subjective assessment on a 1-10 scale from normal skin to worst scar imaginable across 6 metrics (surface area, vascularity, pigmentation, thickness, pliability and relief). The lowest sum score, reflecting normal skin, is 6 and the highest score, reflecting the worst imaginable scar, is 60.
Time frame
From surgery to 9-month clinical endpoint.Secondary outcomes
1
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Incidence of adverse events will be reported for all study participants.
Time frame
From surgery to 9-month clinical endpoint.2
Number of Operative Encounters
The investigators will additionally assess early outcome metrics including number of operative encounters.
Time frame
From surgery to 9-month clinical endpoint.3
Percent Graft Take
The investigators will additionally assess early outcome metrics including percent graft take (% of surface area).
Time frame
From surgery to 9-month clinical endpoint.4
Time to Final Healing/Graft Take
The investigators will additionally assess early outcome metrics including, time to final healing/graft take in days.
Time frame
From surgery to 9-month clinical endpoint.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Armed Forces Institute of Regenerative Medicine
Collaborator
Source ClinicalTrials.gov