Autologous Point-of-Care Adipose Therapy: Recent Injury

Not Applicable

Not yet recruiting

• Conditions: Burns; Contracture Scar; Surgical Injury

• Registration Number: NCT06857448
• Lead Sponsor: University of Pittsburgh

Brief 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.

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 Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-26
• Study First Posted: 2025-03-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Study Start: 2025-06-30
• Primary Completion: 2028-01-31
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Mercy Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States