Autologous Point-of-Care Adipose Therapy: Recent Injury

University of Pittsburgh

Status: Not yet enrolling

Conditions: Contracture Scar; Surgical Injury; Burns

Treatments: Procedure: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).; Procedure: Split Thickness Skin Graft (STSG)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06857448

STUDY24080150 - Recent Injury

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Acute Split Thickness Skin Graft (STSG) Reconstruction

Active Comparator group

Description:

In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by immediate STSG.

Treatment:

Procedure: Split Thickness Skin Graft (STSG)

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

Experimental group

Description:

In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by base of wound fat graft with STSG reconstruction (Autologous Layered Composite Grafting).

Treatment:

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