What is this study trying to find out about soft-tissue injuries from burns and trauma?

This study is evaluating whether using your own fat and skin grafts together can improve healing and reduce scarring in severe soft-tissue injuries. Researchers want to compare this new layered composite grafting method to traditional skin graft techniques. The study is sponsored by the University of Pittsburgh and aims to find better ways to restore function after such injuries.

Who may be eligible for this burns and trauma clinical trial?

Adults aged 18 years or older with full-thickness skin loss or burn injuries on the face, neck, or extremities may be eligible. Both males and females can participate if they are willing to be randomized to receive fat grafting. People with active infections or certain medical concerns may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this burns and trauma clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06857448

Comparing Autologous Fat and Skin Grafting to Traditional Reconstruction for Severe Soft-Tissue Injuries from Burns and Trauma

Led by University of Pittsburgh · Updated on 2026-07-22

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate whether an adipose-based approach can effectively treat full-thickness soft-tissue wounds caused by severe burns or trauma. The study compares a new single-stage method of autologous layered composite grafting, which uses the patients own fat and skin, to traditional reconstruction techniques. The goal is to see if this new method improves healing, reduces scarring, and lowers infection risk for injuries that affect areas with high movement. Participants will be assigned to one of two groups one receiving standard care with immediate split-thickness skin grafting after wound preparation, and the other receiving the layered composite grafting that includes fat harvested via minimally invasive liposuction applied directly to the wound base, followed by skin grafting. Both treatments are performed immediately after injury to support full soft-tissue reconstruction without complex surgery. The study uses a randomized, parallel design with observers blinded to treatment assignments. Throughout the study, participants will be monitored for scar quality using the Patient and Observer Scar Assessment Scale at 9 months post-surgery. Researchers will also assess safety by tracking treatment-related adverse events, healing time, graft success, wound appearance, tissue thickness, flexibility, and mobility. The total study duration for each participant includes surgery and follow-up visits up to 9 months to evaluate healing outcomes and reconstructive effectiveness.

CONDITIONS

Brief Title

Autologous Point-of-Care Adipose Therapy: Recent Injury

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Layered Fat and Skin Graft	Standard Skin Graft
What it is	Surgical procedure combining an autologous (self-donated) fat graft applied directly onto the prepared wound base, followed by a split-thickness skin graft layered over the fat. Fat is harvested via liposuction from the patient and placed without chemical or biologic processing.	Traditional reconstructive procedure involving transplantation of a thin layer of partial-thickness skin (harvested via dermatome) from a donor site to the wound bed, commonly used for traumatic injuries and burn excision with no added base material.
Role in the trial	Investigational surgical approach to evaluate whether adding a base layer of patient's own fat improves scar and tissue outcomes over standard skin graft alone.	Comparator arm using the established split-thickness skin graft technique to serve as the reference for measuring outcomes such as scarring and healing.
Primary use	Treatment of recent complex traumatic, surgical, or burn wounds with the goal of improving scar quality, tissue thickness, vascularity, and patient-reported satisfaction in reconstruction.	Standard care for closing and reconstructing complex skin loss due to trauma, surgery, or burns, supporting wound closure and initial healing.
How it is given or performed	Performed in the operating room: fat is collected via minimally invasive liposuction from the patient, applied to the wound base, and immediately covered with a freshly harvested split-thickness skin graft layer (from thigh, back, or gluteal region). All steps are done at the time of wound reconstruction, using standard surgical techniques.	Standard operating room procedure: a donor skin site is selected (commonly thigh, back, or gluteal area), the partial thickness graft is taken with a dermatome, then transplanted to the prepared wound bed and sutured or stapled in place.
Evidence status	Promising results in case series and small studies suggest potential benefits for scar quality, tissue pliability, and healing, especially after burns or trauma. However, there is limited high-quality randomized evidence in this specific composite approach, making this trial important to clarify comparative effectiveness and longer-term outcomes.	Well-supported by decades of surgical practice, randomized trials, and guidelines for wound closure and healing. Some limitations exist for long-term scar quality, graft contraction, and functional outcomes, especially in complex or deep wounds.
Important limitations	More complex than standard skin grafting, requires additional fat harvest site, and long-term benefits over standard care remain uncertain due to limited robust trial data. Technical factors and patient selection may affect graft success and complication rates.	Common limitations include hypertrophic or contracture scarring, color/texture mismatch, reduced pliability, and risk of incomplete graft take or secondary procedures. Cosmetic and functional outcomes are not always ideal for extensive or deep wounds.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 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 due to non-infectious causes
Having unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck, or extremities needing reconstruction
Having full or partial thickness burn injury of the face, neck, or extremity requiring excision and/or reconstruction
Willingness to be randomized to receive a fat graft

You will not qualify if you...

Under 18 years of age
Active infection
Medical conditions or anatomy that raise safety concerns as judged by a physician
Unable or unwilling to follow study procedures
Radiation treatment to the injury site
Prisoners or vulnerable populations
Pregnant or planning pregnancy within the next year

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single-stage procedure at enrollment

Participants receive either the traditional split-thickness skin graft or the experimental layered composite grafting, which includes fat grafting combined with skin grafts, for soft-tissue reconstruction.

Surgical procedure and immediate post-operative care

Follow-up

Duration - Up to 9 months

Participants are monitored for healing, scar quality, and safety outcomes for up to 9 months after surgery.

Regular follow-up visits to assess scar healing and adverse events