RecruitingNot ApplicableNCT06857448

Autologous Point-of-Care Adipose Therapy: Recent Injury

Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Recent Injury

Sponsor

University of Pittsburgh

Enrollment

68 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Burns Surgical Injury Contracture Scar

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURESplit Thickness Skin Graft (STSG)

Partial thickness skin in STSGs are performed by harvesting via dermatome the donor site. Donor sites are typically taken from a flat surface on the thigh, lower back, or gluteal region to allow for a graft of even thickness and the selection of donor site is to be based on clinical standard practice. These grafts are placed on the prepared recipient site.

PROCEDUREBase of wound fat graft with 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.