Field Shield Wound Dressing Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Wounds - Partial Thickness (2nd Degree)
• Intervention / Treatment: Device: Field Shield Wound Dressing; Device: Silverlon

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerriann Greenhalgh, Ph.D.; Phone Number: 813-391-7722; Email: kgreenha@kericure.com
• Study Contact Backup: Name: Pam Sovine; Email: Pam@kericure.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 82008
      • Recruiting
      • ValleyWise Health
      • Principal Investigator: Kevin Foster, MD
      • Contact: Natalie Kesler, BSN; Phone Number: 602-344-5726; Email: natalie.kesler@valleywisehealth.org
  • Texas
    • San Antonio, Texas, United States, 78234
      • Active, not recruiting
      • United State Army Institute of Surgical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FSWD wound site; One burn wound site on each participant will receive study treatment.	Device: Field Shield Wound Dressing; Spray on wound dressing.
Active Comparator: Control treatment; One burn wound site on each patient receives standard treatment with silver dressing.	Device: Silverlon; Silver dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound closure	Wound closure will be assessed at each time point (day 3, 7, 12, 19, 28, 35). The probability of wound closure will be assessed with a cluster randomized Generalized Estimating Equations (GEE) model of the probability of closure in terms of treatment and clinical site with clustering by patient and login link.	From enrollment to end of study, 4-6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection	Rate of occurrence of infection per uint time.	35 days
Surgical debridement	Rate of occurrence of surgical debridement and rate of occurrence of grafting	35 days
Pain severity	Pain will measured using a visual analog scale (0-10) at each dressing change comparing each site pain ratings.	days 3, 7, 12, 19, and 28.
Scar	The Patient and Observer Scar Assessment Scale will be conducted to evaluate scars, comparing the two sites at two time points.	day 35 and 4-6 months
Health-related quality of life	A burn specific health-related quality of life assessment will be conducted and compared at two time points.	day 35 and 4-6 months
Function	The Patient Specific Function Scale assessment will be conducted and compared at three time points	Day 3, 35 and 4-6 months

Collaborators and Investigators

• Sponsor: KeriCure Medical
• Collaborators: The University of Texas Health Science Center at San Antonio; Valleywise Health; United States Army Institute of Surgical Research
• Investigators: Principal Investigator: Kerriann Greenhalgh, PH.D., KeriCure Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 29, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Burn wounds; FSWD
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 20240572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected de-identified IPD that underlie results in a publication.
• IPD Sharing Time Frame: January 1, 2027
• IPD Sharing Access Criteria: Data will be submitted to the National Trauma Research Repository. Access will be limited to investigators with approved access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No