Field Shield wound dressing for partial-thickness (second-degree) burns
Official title: Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds
Run by KeriCure Medical · NCT07337616 · Data updated 2026-11-12
This trial tests whether the Field Shield Wound Dressing heals second-degree burn wounds faster and with less pain and infection than a standard silver dressing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | KeriCure Medical Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | July 30, 2026 |
| Study ends | September 29, 2026 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT07337616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with intermediate-to-deep partial-thickness thermal burns covering 5–30% TBSA, admitted to a participating burn center within 72 hours and having two comparable wound areas of at least 100 cm2, who can follow study procedures, are ideal candidates.
✕Probably not a fit
Patients with full-thickness burns, burns smaller than 5% TBSA, or excluded medical conditions (e.g., congestive heart failure, oxygen-dependent lung disease, end-stage renal disease, liver cirrhosis), active cancer treatment, hospice care, or known allergies to silver or lidocaine are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with intermediate-to-deep partial-thickness thermal burns (5–30% TBSA) admitted within 72 hours who have two comparable wound areas will receive the Field Shield Wound Dressing on one area and a Silverlon dressing on the other. Dressing changes and standardized visual assessments will be performed to track healing, infection, pain/discomfort, and any deepening of the wounds over time. The within-patient paired design reduces inter-subject variability and enables direct comparison of wound outcomes between the two dressings. The trial is run at Valleywise Health (Phoenix) and the U.S. Army Institute of Surgical Research (San Antonio) in collaboration with KeriCure Medical and UT Health San Antonio.
Why it matters
Potential benefit: If successful, this dressing could speed healing, reduce infection and pain, and limit progression to deeper wounds or scarring.
How similar studies have gone: Silver-containing dressings such as Silverlon have shown benefits in reducing infection and supporting healing in prior studies, but direct head-to-head comparisons with the newer Field Shield dressing are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Thermal injury size 5-30% TBSA * Admitted to the burn center and enroll able within 72 hours of injury * Subject has two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns (study sites). These areas are judged to be comparable in depth. * The subject and or caregiver is able and willing to follow the protocol requirements * Achieve wound photos and dressing change at 3 days Exclusion Criteria: * Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis * Subject is undergoing hospice care. * Subject is currently being treated for an active malignant disease * Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety * Known contraindications to silver metals, silver chloride, or silver tetraoxide * Known contraindications to lidocaine * Known allergies to any components of either primary dressing in the study * Known allergies to the silicone or adhesives in secondary dressings * Burns located on the hands, feet, face, and/or genitals will be excluded from treatment sites, but will be included in the total TBSA calculation * Subject has a combined TBSA of 31% or greater of partial and/or full thickness burn wounds * Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. * Subject is pregnant, breast feeding, or planning to become pregnant. * Subjects who, within 60 days prior to enrollment, have a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, application of topical steroids within one month prior to enrollment, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. * Burn study site(s) has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) preceding the study wound dressing application. * Burn study site(s) has been previously treated with a silvadene
Where it's running
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Valleywise Health
Phoenix, Arizona, United States Recruiting -
United State Army Institute of Surgical Research
San Antonio, Texas, United States Active not recruiting
Study contacts
- Principal investigator: Kerriann Greenhalgh, PH.D. — KeriCure Medical
- Study coordinator: Kerriann Greenhalgh, Ph.D.
- Email: kgreenha@kericure.com
- Phone: 813-391-7722
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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KJ101 for debridement of deep second-degree burns
This trial will test whether topical KJ101 helps remove dead tissue and promote healing in adults with deep second-degree burns compared with chymotrypsin and placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.