Autologous Point-of-Care Adipose Therapy: Recent Injury

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT06857448
Status
Not Yet Recruiting

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Conditions

  • Burns
  • Contracture Scar
  • Surgical Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Split Thickness Skin Graft (STSG) — PROCEDURE
    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.
  • Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Acute Split Thickness Skin Graft (STSG) Reconstruction
    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.
  • Experimental: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
    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).

Primary Outcome Measure

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. [ Time Frame: From surgery to 9-month clinical endpoint. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mercy HospitalPittsburghPennsylvania15219
Eleanor Shirley
[email protected]
412-641-8676
Francesco Egro (PRINCIPAL_INVESTIGATOR)
Presbyterian HospitalPittsburghPennsylvania15219
Eleanor Shirley
[email protected]
412-641-8676
Teun Teunis (SUB_INVESTIGATOR)

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By research site
Mercy Hospital· Pittsburgh, PAPresbyterian Hospital· Pittsburgh, PA

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