Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

Conditions

• Burns
• Contracture Scar
• Surgical Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Full Thickness Skin Graft (FTSG) — PROCEDURE
  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). — 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 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.

Key Dates

Start date

Dec 31, 2025

Status verified

Nov 2025

Primary completion

Jan 31, 2028

Completion

Oct 30, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Eleanor Shirley
  412-641-8676
  [email protected]
• Patsy Simon
  412-641-8676
  [email protected]

Locations (2)

Find similar trials in Pittsburgh, PA

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