Recruiting

Autologous Grafting

Sponsor:

University of Pittsburgh

Code:

NCT06857435

Conditions

Burns

Contracture Scar

Surgical Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Full Thickness Skin Graft (FTSG)

Base of wound fat graft with Split Thickness Skin Graft (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 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.

Conditions

Burns

Contracture Scar

Surgical Injury

Study ID

NCT06857435

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 scar contracture release and reconstruction at any level.
  • 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

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Delayed Full Thickness Skin Graft (FTSG) Reconstruction

In this Arm, the investigators will assess FTSGs for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a FTSG.

experimental: Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)

In this Arm, the investigators will assess Autologous Layered Composite Grafting for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a Autologous Layered Composite Graft.

Interventions

Full Thickness Skin Graft (FTSG)

Full 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).

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

  • Change in scar contracture, as measured by change in scar surface area size [ 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

  • burns
  • scar contracture

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.