Fat Grafting for Burns

Recruiting at 1 trial location

Overseen By Patsy Simon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate

68 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Autologous Point-of-Care Adipose Therapy for burns?

Research shows that fat grafting, which involves using a person's own fat, has been effective in improving tissue quality in cases of thermal injury and wound healing. Studies highlight the regenerative potential of fat cells, which can help reduce wound size and promote healing, especially when used repeatedly. ^{1 2 3 4 5}

Is autologous fat grafting safe for use in humans?

Autologous fat grafting, which uses a person's own fat for treatment, generally has a reliable safety profile, but complications can occur, including serious ones. Studies have shown that when used for various conditions, such as wound healing and bone repair, it has been safe with no serious adverse events reported for up to 54 months. ^{2 4 6 7 8}

How is the treatment Autologous Point-of-Care Adipose Therapy different from other treatments for burns?

Autologous Point-of-Care Adipose Therapy is unique because it uses the patient's own fat, which contains stem cells that can help regenerate and heal damaged tissue. This approach is different from other treatments as it not only addresses cosmetic concerns but also improves tissue quality and reduces pain, with minimal risk of complications. ^{1 4 9 10 11}

Research Team

Francesco Egro

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals with full-thickness soft-tissue trauma, such as severe burns or significant tissue loss. Participants should have recent injuries that might benefit from advanced wound healing techniques. The study excludes those who may not be suitable due to specific medical conditions or factors determined by the researchers.

Inclusion Criteria

I am an adult needing a fasciotomy due to non-infectious reasons.

I am open to receiving a fat graft if chosen.

I need reconstruction due to severe skin loss from injury on my face, head, neck, or limbs.

Exclusion Criteria

Unwilling or unable to comply with study procedures

I have received radiation therapy to the area being studied.

I currently have an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immediate autologous adipose and autologous layered composite grafting for acute functional soft-tissue reconstruction

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of graft take, healing, and scar appearance

9 months

Regular visits (in-person)

Treatment Details

Interventions

• Autologous Point-of-Care Adipose Therapy

Trial Overview The study tests a new method of wound treatment using patients' own fat (autologous adipose) combined with skin grafting (Autologous Layered Composite Grafting). It compares this single-stage procedure against traditional methods to assess improvements in healing, scarring reduction, and infection prevention.

Participant Groups

Group I: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). Experimental Treatment 1 Intervention

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).

Group II: Acute Split Thickness Skin Graft (STSG) Reconstruction Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Armed Forces Institute of Regenerative Medicine

Collaborator

Trials

7

Recruited

220+

Findings from Research

The study evaluated the safety and efficacy of autologous adipose-derived stem cell (ASC) therapies in 17 patients with severe conditions, finding no serious adverse events over a follow-up period of up to 54 months.

Both ASC-derived products—a scaffold-free osteogenic graft for bone non-union and a biological dressing for chronic wounds—were successfully manufactured and implanted without contamination or genomic issues, demonstrating their feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. Vériter, S., André, W., Aouassar, N., et al.[2022]

Doppler-ultrasound (DUS) imaging was successfully used in a study of 20 female patients (average age 57.9 years) to safely guide the harvesting and injection of autologous fat for facial lipofilling, helping to visualize and avoid the temporal artery during the procedure.

The study reported only one case of edema and nodules, indicating a favorable safety profile for DUS-guided lipofilling, suggesting that DUS should be considered an essential part of the procedure to enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. Kadouch, J., Schelke, LW., Swift, A.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Fat grafting for thermal injury: current state and future directions. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Autologous Fat Grafting in the Treatment of Acute and Chronic Cutaneous Wounds. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term Results After Autologous Fat Transfer for Treatment of Chronic Lower Extremity Wounds. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Protocol for a systematic review of autologous fat grafting for wound healing. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Autologous fat injection therapy including a high concentration of adipose-derived regenerative cells in a vocal fold paralysis model: animal pilot study. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Association of Autologous Fat Injection in Facial Artery With Ophthalmological Complications: An Experimental Animal Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Review: Proposed Methods to Improve the Survival of Adipose Tissue in Autologous Fat Grafting. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Autologous fat grafting alleviates burn-induced neuropathic pain in rats. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Autologous fat grafting for correction of unaesthetic scars. [2022]