An interventional study of Split Thickness Skin Graft (STSG) and Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). in Burns, Contracture Scar and Surgical Injury, sponsored by University of Pittsburgh. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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:
Soft-tissue injuries from blasts, burns, or multiple traumas can cause severe damage, leading to loss of function, lower quality of life, long recovery times, and inability to work. When these injuries involve deep burns or full-thickness tissue loss in areas that move a lot, they are especially difficult to treat due to the risk of scarring, stiffness, and tissue sticking together. There is a need for a reliable, single-stage treatment that can provide soft, flexible tissue reconstruction with minimal risk, cost, and, complexity. To address this issue, the investigators propose a fat-based approach to reconstruction. Fat tissue is easily available from the patient's own body and carries many benefits in reconstructive surgery. Our team has shown that using a layer of fat immediately in treatment creates a soft, vascular layer that reduces scarring, improves tissue volume, and supports a one-stage, multi-layer reconstruction without the need for complex surgery or causing harm to the donor area. The purpose of this study is to compare this reconstructive approach under the following conditions:
Evaluators including dedicated observers will be blinded to treatment group/strategy.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 68 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by immediate STSG.
Procedure: Split Thickness Skin Graft (STSG)
In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by base of wound fat graft with STSG reconstruction (Autologous Layered Composite Grafting).
Procedure: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
Partial 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.
Autologous 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.
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.
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.
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.
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.
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.
Photographic Appearance of Wound
Photographic evaluation for wound appearance. This is gross appearance.
Time frame: From surgery to 9-month clinical endpoint.
Area of Wound
Photographic evaluation for size of wound area. This is measured in cm2
Time frame: From surgery to 9-month clinical endpoint.
Tissue Thickness
The investigators will measure tissue thickness as determined by ultrasound.
Time frame: From surgery to 9-month clinical endpoint.
Pliability (Tensiometry/Cutometry)
The investigators will utilize a noninvasive cutometer/tensiometer to determine tissue pliability.
Time frame: From surgery to 9-month clinical endpoint.
Tissue Mobility (Resistance to Adhesion)
The investigators will measure tissue mobility under non-invasive tissue stretch. Measurement is achieved by the mm of stretch achievable from a given point under a standardized stress.
Time frame: From surgery to 9-month clinical endpoint.
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Jan 2028, 26 months after the start.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 26 months is above that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
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