Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
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 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 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 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
Design model
Parallel
Treatments tested in this trial
Full Thickness Skin Graft (FTSG)
Procedure/SurgeryFull thickness skin in FTSGs are harvested by different means by surgeon preference and standard of care. Typically an area of skin with matching color and texture to the site which needs reconstruction is identified from a hidden and/or non-cosmetic area and collected via excision. After excision the donor site is closed and the graft is thinned by using a scalpel or scissors to remove excess fat or other soft tissues from the deep surface before being placed in the donor site.
Base of wound fat graft with Split Thickness Skin Graft (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
40 Participants
are divided into 2 treatment groupsGroup A: Delayed Full Thickness Skin Graft (FTSG) ReconstructionActive comparator 1 intervention
Group B: Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in scar contracture, as measured by change in scar surface area size
Contracture as measured by change in surface area of reconstruction between time of surgery and 9-month clinical endpoint/maturation of reconstruction. These data will be derived by serial photography.
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
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. Remove
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.3
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.4
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.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