Fat Grafting for Burns

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether using a person's own fat tissue (Autologous Point-of-Care Adipose Therapy) can heal severe burns or soft-tissue injuries more effectively than traditional methods. The trial focuses on whether immediate fat grafting, combined with a skin graft, improves healing, reduces scarring, and lowers infection risk. Participants will receive either the new treatment or standard care for comparison. Ideal candidates are those with serious burns or skin loss on the face, neck, or limbs who have been advised to undergo reconstructive surgery. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this adipose-based therapeutic strategy is safe for treating full-thickness soft-tissue trauma wounds?

Research has shown that using a patient's own body fat for treatment, known as autologous fat grafting, is generally well-tolerated. Studies indicate that this method can be safe for treating soft-tissue wounds like burns. Since the fat comes from the patient's own body, the risk of rejection or allergic reaction is lower.

Previous patients have reported few side effects, with common ones including temporary swelling or bruising where the fat was taken or placed. Serious side effects are rare.

This method remains under study, but current evidence suggests it is a safe option for those with severe burns or tissue loss. It is important to consult medical professionals to better understand individual circumstances. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Autologous Point-of-Care Adipose Therapy because it introduces a new way to enhance healing for burn injuries. Unlike standard treatments, which typically focus on skin grafts alone, this method involves using the patient's own fat as a grafting layer. This approach not only aims to improve the cosmetic and functional outcomes by reducing contour irregularities, adhesions, and contractures but also potentially speeds up recovery. By layering fat grafts under traditional skin grafts, the treatment offers a novel mechanism that could lead to better integration and healing of the grafted skin.

What evidence suggests that this trial's treatments could be effective for burn wounds?

Research has shown that using autologous fat grafting can help heal and improve scars from burns and other injuries. This trial will evaluate one arm using autologous fat grafting combined with Split Thickness Skin Graft (STSG) reconstruction. Studies have found that this method can aid in wound healing, reduce scarring, and enhance the skin's appearance and function. Some patients have reported greater satisfaction with their scars' appearance after this treatment. However, not all studies agree; one study found it did not improve mature burn scars in children. Overall, early evidence suggests this therapy might be beneficial for certain types of burn and injury scars. ^{1 2 3 5 6}

Who Is on the Research Team?

Francesco Egro

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06857448

Autologous Point-of-Care Adipose Therapy: 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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11025588/

Autologous fat grafting and adipose-derived stem cells ... It is used successfully in cases such as improving radiation-induced skin damage[4], facilitating wound healing, promoting scar remodeling[5], and managing burn ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT06857448

Autologous Point-of-Care Adipose Therapy: 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, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030541791630393X

Autologous fat grafting does not improve burn scar ... Conclusions. Single treatment with autologous fat grafts did not improve mature pediatric burn scars when compared to normal saline injections.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12596688/

The Utility of Fat Grafting to Manage Burn Scars This systematic review suggests that autologous fat grafting and ADSCs show promising results for improving scar quality, function, and patient satisfaction ...

6. trial.medpath.com trial.medpath.com/clinical-trial/dbe20752fa06cd96/autologous-adipose-therapy-skin-reconstruction

Autologous Point-of-Care Adipose Therapy: 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, ...