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NOT YET RECRUITING
NCT06857448
NA

Autologous Point-of-Care Adipose Therapy: Recent Injury

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2025-12

Completion Date

2028-10-30

Last Updated

2025-11-05

Healthy Volunteers

No

Interventions

PROCEDURE

Split 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.

PROCEDURE

Base 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.

Locations (2)

Mercy Hospital

Pittsburgh, Pennsylvania, United States

Presbyterian Hospital

Pittsburgh, Pennsylvania, United States