RecruitingNot ApplicableNCT06857435

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

Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Delayed Injury/Scar


Sponsor

University of Pittsburgh

Enrollment

40 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria7

  • 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.

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Interventions

PROCEDUREFull 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.

PROCEDUREBase 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.


Locations(2)

Mercy Hospital

Pittsburgh, Pennsylvania, United States

Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

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NCT06857435


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