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Field Shield Wound Dressing Study | Clinical Trials | Clareo Health

RECRUITINGNA

Field Shield Wound Dressing Study

Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds

NCT07337616•KeriCure Medical

Summary

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.

Detailed Description

To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (2)

Valleywise Health

Phoenix, Arizona, United States

United State Army Institute of Surgical Research

San Antonio, Texas, United States

Key Dates

Start Date

May 1, 2025

Primary Completion Date

July 30, 2026

Completion Date

September 29, 2026

Last Updated

January 13, 2026

Enrollment

ESTIMATED participants

Conditions

Burn Wounds - Partial Thickness (2nd Degree)

Interventions

Field Shield Wound Dressing

DEVICE

Silverlon

DEVICE

Contacts

Kerriann Greenhalgh, Ph.D.

CONTACT

813-391-7722 kgreenha@kericure.com

Pam Sovine

CONTACT

Pam@kericure.com

Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns

NCT07025408

BurnBurn Wounds - Partial Thickness (2nd Degree)

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WITHDRAWN

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NCT06760611

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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