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NCT06857435 | NOT YET RECRUITING | Burns

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

Condition or disease

Burns

Contracture Scar

Surgical Injury

Intervention/treatment

Full Thickness Skin Graft (FTSG)

Base of wound fat graft with Split Thickness Skin Graft (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 non-inferiority of autologous layered composite grafting to full-thickness skin grafting for delayed reconstruction of post-burn/trauma scar contracture. Evaluators including dedicated observers will be blinded to treatment group/strategy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Delayed Injury/Scar
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 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.
Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

Location Details

NCT06857435

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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