Field Shield Wound Dressing Study

NCT07337616 | Recruiting FDA Device

• 1 other identifier: 20240572
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Burn Wounds - Partial Thickness (2nd Degree)

Keywords

FSWD; Burn wounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Infection

  35 days

• Surgical debridement

  35 days

• Pain severity

  days 3, 7, 12, 19, and 28.

• Scar

  day 35 and 4-6 months

• Health-related quality of life

  day 35 and 4-6 months

Study Arms (2)

FSWD wound site

EXPERIMENTAL

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

Device: Field Shield Wound Dressing

Control treatment

ACTIVE COMPARATOR

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

Device: Silverlon

Interventions

Field Shield Wound Dressing DEVICE

Spray on wound dressing.

FSWD wound site

Silverlon DEVICE

Silver dressing

Control treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KeriCure Medical: lead
• Valleywise Health: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• United States Army Institute of Surgical Research: collaborator

Study Sites (2)

Valleywise Health

Phoenix, Arizona, 82008, United States

RECRUITING

United State Army Institute of Surgical Research

San Antonio, Texas, 78234, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kerriann Greenhalgh, PH.D.

  KeriCure Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerriann Greenhalgh, Ph.D.

CONTACT

813-391-7722; kgreenha@kericure.com

Pam Sovine

CONTACT

Pam@kericure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the individual performing dressing changes will know which dressing is applied to which site. All others will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this study each subject will serve as their own control receiving the intervention dressing on one wound and the standard of care dressing on another wound.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 13, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 1, 2027
• Access Criteria: Data will be submitted to the National Trauma Research Repository. Access will be limited to investigators with approved access.

Locations

US (2)