Autologous Point-of-Care Adipose Therapy: Recent Injury

November 3, 2025 updated by: Francesco Egro, University of Pittsburgh

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Francesco Egro
      • Pittsburgh, Pennsylvania, United States, 15219
        • Presbyterian Hospital
        • Contact:
        • Sub-Investigator:
          • Teun Teunis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acute Split Thickness Skin Graft (STSG) Reconstruction
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.
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.
Experimental: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score on the Patient and Observer Scar Assessment Scale (POSAS): Pigmentation, Pliability, Vascularity, Thickness, Relief, and Surface Area, collected at the 9 month follow up visit.
Time Frame: From surgery to 9-month clinical endpoint.
POSAS measures subjective assessment on a 1-10 scale from normal skin to worst scar imaginable across 6 metrics (surface area, vascularity, pigmentation, thickness, pliability and relief). The lowest sum score, reflecting normal skin, is 6 and the highest score, reflecting the worst imaginable scar, is 60.
From surgery to 9-month clinical endpoint.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Time Frame: From surgery to 9-month clinical endpoint.
Incidence of adverse events will be reported for all study participants.
From surgery to 9-month clinical endpoint.
Number of Operative Encounters
Time Frame: From surgery to 9-month clinical endpoint.
The investigators will additionally assess early outcome metrics including number of operative encounters.
From surgery to 9-month clinical endpoint.
Percent Graft Take
Time Frame: From surgery to 9-month clinical endpoint.
The investigators will additionally assess early outcome metrics including percent graft take (% of surface area).
From surgery to 9-month clinical endpoint.
Time to Final Healing/Graft Take
Time Frame: From surgery to 9-month clinical endpoint.
The investigators will additionally assess early outcome metrics including, time to final healing/graft take in days.
From surgery to 9-month clinical endpoint.
Tissue Thickness
Time Frame: From surgery to 9-month clinical endpoint.
The investigators will measure tissue thickness as determined by ultrasound.
From surgery to 9-month clinical endpoint.
Pliability (Tensiometry/Cutometry)
Time Frame: From surgery to 9-month clinical endpoint.
The investigators will utilize a noninvasive cutometer/tensiometer to determine tissue pliability.
From surgery to 9-month clinical endpoint.
Photographic Appearance of Wound
Time Frame: From surgery to 9-month clinical endpoint.
Photographic evaluation for wound appearance. This is gross appearance.
From surgery to 9-month clinical endpoint.
Area of Wound
Time Frame: From surgery to 9-month clinical endpoint.
Photographic evaluation for size of wound area. This is measured in cm2
From surgery to 9-month clinical endpoint.
Tissue Mobility (Resistance to Adhesion)
Time Frame: From surgery to 9-month clinical endpoint.
The investigators will measure tissue mobility under non-invasive tissue stretch. Measurement is achieved by the mm of stretch achievable from a given point under a standardized stress.
From surgery to 9-month clinical endpoint.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Armed Forces Institute of Regenerative Medicine

Investigators

  • Principal Investigator: Francesco Egro, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24080150 - Recent Injury

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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