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 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 evaluate healing, infection, pain/discomfort, and deepening of wound over time.

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+