Field Shield Wound Dressing for Partial Thickness Burns

Recruiting at 1 trial location

Overseen By Pam Sovine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: KeriCure Medical

Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids, others

Disqualifiers: Heart failure, Lung disease, Cancer, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4-6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wound dressing called the Field Shield Wound Dressing (FSWD) for treating partial thickness burns. The goal is to evaluate its effectiveness in healing, infection prevention, and pain reduction compared to standard silver dressings. Participants must have burns covering 5-30% of their body and two distinct burn areas similar in depth and size. This trial may suit individuals who can adhere to the procedures and have not undergone certain treatments or conditions that might affect the study. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance burn treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, chemotherapy, or topical steroids, you may not be eligible to participate.

What prior data suggests that the Field Shield Wound Dressing is safe for treating burn wounds?

Research shows that the Field Shield Wound Dressing (FSWD) aids in healing burn wounds. An earlier study found that FSWD led to fewer complications compared to traditional silver dressings, suggesting it might be gentler on the body.

Although specific safety data for FSWD in humans is not yet available, the study focuses on healing and discomfort, ensuring close monitoring of safety. As this treatment is in the early testing phase, information on human reactions may be limited. However, early-stage studies typically include strict safety checks.

Prospective trial participants can be assured that researchers are carefully evaluating the treatment for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Field Shield Wound Dressing is unique because it offers a new way to treat partial thickness burns, potentially improving healing time and comfort compared to traditional silver dressings. Researchers are excited because this dressing might provide a more breathable, flexible, and easier-to-apply option, which could lead to faster recovery and less pain for patients. Unlike standard treatments, which often rely on antimicrobial properties of silver, the Field Shield aims to enhance the wound healing environment without relying solely on antimicrobial action, offering a novel approach to burn care.

What evidence suggests that the Field Shield Wound Dressing is effective for partial thickness burns?

Research has shown that the Field Shield Wound Dressing (FSWD) can help treat partial-thickness burns. One study compared FSWD to silver dressings and found similar healing times. However, FSWD caused less disruption to the wound, aiding in healing. In this trial, one burn wound site on each participant will receive FSWD treatment, while another site will receive standard treatment with a silver dressing for comparison. Another study found that FSWD did not cause burns to spread, unlike some other treatments. These results suggest that FSWD might help wounds heal with less pain and scarring. ^{1 3 6 7 8}

Who Is on the Research Team?

Kerriann Greenhalgh, PH.D.

Principal Investigator

KeriCure Medical

Are You a Good Fit for This Trial?

This trial is for individuals admitted to a burn center within 72 hours of sustaining thermal burns covering 5-30% of their body. They must have two distinct areas with intermediate to deep partial thickness burns suitable for the study, be able and willing to follow protocol, and attend dressing changes at 3 days.

Inclusion Criteria

My burn covers 5-30% of my body.

I can provide photos of my wound and change its dressing 3 days post-treatment.

I was admitted to the burn center within 3 days of my injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Field Shield Wound Dressing or standard silver dressing for burn wounds

4-6 months

Visits on days 3, 7, 12, 19, 28, 35

Follow-up

Participants are monitored for wound closure, infection, pain, scar assessment, quality of life, and function

4-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Field Shield Wound Dressing

Trial Overview

The Field Shield Wound Dressing (FSWD) is being compared with a standard care wound dressing in treating burn wounds. The study will assess healing speed, infection rates, pain or discomfort levels, and whether the wound's severity increases over time.

How Is the Trial Designed?

Group I: FSWD wound site Experimental Treatment 1 Intervention

One burn wound site on each participant will receive study treatment.

Group II: Control treatment Active Control 1 Intervention

One burn wound site on each patient receives standard treatment with silver dressing.

Who Is Running the Clinical Trial?

KeriCure Medical

Lead Sponsor

Valleywise Health

Collaborator

Trials

15

Recruited

3,500+

United States Army Institute of Surgical Research

Collaborator

Trials

30

Recruited

1,800+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07337616?term=NA

NCT07337616 | Field Shield Wound Dressing Study

This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to ...

2.

narescue.com

narescue.com/downloadable/download/sample/sample_id/2786/?srsltid=AfmBOooJMXFaQcFNRospfp-uWusVOUarrX7YJJZTEeSarFW1dSzpWKTZ

Evaluation of Field Shield Wound Dressing for Improved ...

Data represents the average of all 3 animals. Silverlon burns had statistically significant expansion during PFC treatment window, whereas FSWD1 and. ASAP ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5700875/

A Prospective, Randomized, Controlled Trial Comparing ...

... the treatment of partial-thickness burn wounds in an outpatient setting. Both dressings have comparable healing times. Reduced disturbance of the wound bed ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/86f8a151115443ab/nct07337616-field-shield-wound-dressing-burn-wounds

Field Shield Wound Dressing Study | MedPath

This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0079642524001191

Enhancing wound healing and minimizing scarring

Electrospun nanofibrous wound dressings have emerged as a promising option for promoting scar-free wound healing.

6.

withpower.com

withpower.com/trial/phase-burns-4-2025-c0d9d

Field Shield Wound Dressing for Partial Thickness Burns

The study will assess healing speed, infection rates, pain or discomfort levels, and whether the wound's severity increases over time. How Is ...

7.

nattrauma.org

nattrauma.org/fswd-study/

KeriCure Medical and CNTR Begin First Clinical Trial on ...

Greenhalgh said she expects the trial will show that Field Shield Wound Dressing results in better healing with fewer complications. About ...

8.

narescue.com

narescue.com/downloadable/download/sample/sample_id/2786/?srsltid=AfmBOorGm2lE78hny_Mleyc7xBpQQ5bE2e-O3rTG22Li6ykOHVcaEX57

Evaluation of Field Shield Wound Dressing for Improved ...

Data represents the average of all 3 animals. Silverlon burns had statistically significant expansion during PFC treatment window, whereas FSWD1 and. ASAP ...