Recruiting

Autologous Grafting

Sponsor:

University of Pittsburgh

Code:

NCT06857448

Conditions

Burns

Contracture Scar

Surgical Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Split Thickness Skin Graft (STSG)

Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).

Study Details

Brief summary:

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.

Conditions

Burns

Contracture Scar

Surgical Injury

Study ID

NCT06857448

Start date

Nov 4, 2025

Status verified date

Jul, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • secondary to non-infectious etiology,
  • unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck or extremities necessitating reconstruction, and/or
  • full or partial thickness burn injury of the face, neck, or extremity requiring excision and/or reconstruction.
  • Additional inclusion criteria includes willingness to be randomized to receive a fat graft.

Exclusion Criteria:

  • 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,
  • radiation to the site of interest,
  • prisoners and/or vulnerable populations.
  • In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Split Thickness Skin Graft (STSG)

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).

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.

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 and Locations

Central contacts

Eleanor Shirley

412-641-8676shirleye@upmc.edu

Patsy Simon

412-641-8676simopa@UPMC.EDU

Locations

Mercy Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Eleanor Shirley

412-641-8676shirleye@upmc.edu

Principal Investigator:

Francesco Egro

Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Eleanor Shirley

412-641-8676shirleye@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • fasciotomy
  • trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-22.