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NCT06857448 | NOT YET RECRUITING | Burns

Autologous Point-of-Care Adipose Therapy: Recent Injury
Sponsor:

University of Pittsburgh

Information provided by (Responsible Party):

Francesco Egro

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.

Condition or disease

Burns

Contracture Scar

Surgical Injury

Intervention/treatment

Split Thickness Skin Graft (STSG)

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

Phase

NA

Detailed Description:

Soft-tissue injuries from blasts, burns, or multiple traumas can cause severe damage, leading to loss of function, lower quality of life, long recovery times, and inability to work. When these injuries involve deep burns or full-thickness tissue loss in areas that move a lot, they are especially difficult to treat due to the risk of scarring, stiffness, and tissue sticking together. There is a need for a reliable, single-stage treatment that can provide soft, flexible tissue reconstruction with minimal risk, cost, and, complexity. To address this issue, the investigators propose a fat-based approach to reconstruction. Fat tissue is easily available from the patient's own body and carries many benefits in reconstructive surgery. Our team has shown that using a layer of fat immediately in treatment creates a soft, vascular layer that reduces scarring, improves tissue volume, and supports a one-stage, multi-layer reconstruction without the need for complex surgery or causing harm to the donor area. The purpose of this study is to compare this reconstructive approach under the following conditions: • Demonstrate efficacy of immediate autologous adipose and autologous layered Composite Grafting in acute functional soft-tissue reconstruction. Evaluators including dedicated observers will be blinded to treatment group/strategy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 68 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Recent Injury
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2028-01-31
Estimated Study Completion Date : 2028-10-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Autologous Point-of-Care Adipose Therapy: Recent Injury

Location Details

NCT06857448

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How to Participate

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Locations

Not yet recruiting

United States, Pennsylvania

Mercy Hospital

Pittsburgh, Pennsylvania, United States, 15219

Not yet recruiting

United States, Pennsylvania

Presbyterian Hospital

Pittsburgh, Pennsylvania, United States, 15219