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Search / Trial NCT06857448

Autologous Point-of-Care Adipose Therapy: Recent Injury

Launched by UNIVERSITY OF PITTSBURGH · Feb 26, 2025

Trial Information

Current as of July 25, 2025

Not yet recruiting

Keywords

Fasciotomy Trauma

ClinConnect Summary

This clinical trial is exploring a new treatment method to help people who have suffered serious injuries, such as severe burns or wounds that require extensive repair. The researchers want to see if using a patient’s own fat (called adipose tissue) can improve healing and reduce scarring when applied directly to the wound right after an injury. Participants will receive this fat grafting along with a skin graft in a single procedure, and the study will compare this method with traditional healing techniques to determine which one works better.

To be eligible for this study, participants must be adults aged 18 or older, either male or female, and can include civilians, military personnel, or veterans. They should have significant injuries, like full-thickness skin loss from trauma or burns that need reconstruction. However, individuals with active infections, certain medical conditions, or those who are pregnant cannot participate. If you choose to join this study, you will receive immediate treatment that aims to improve your recovery experience. The trial is still in the planning stages and is not yet recruiting participants.

Gender

ALL

Eligibility 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.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Francesco Egro

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported