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NCT Number: NCT07337616

Field Shield Wound Dressing Study

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valleywise Health, Phoenix, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Field Shield Wound Dressing

Device

Spray on wound dressing.

Silverlon

Device

Silver dressing

Primary outcomes

  1. Wound closure

    Time frame: From enrollment to end of study, 4-6 months.

    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.

Secondary outcomes

  1. Infection

    Time frame: 35 days

    Rate of occurrence of infection per uint time.

  2. Surgical debridement

    Time frame: 35 days

    Rate of occurrence of surgical debridement and rate of occurrence of grafting

  3. Pain severity

    Time frame: days 3, 7, 12, 19, and 28.

    Pain will measured using a visual analog scale (0-10) at each dressing change comparing each site pain ratings.

  4. Scar

    Time frame: day 35 and 4-6 months

    The Patient and Observer Scar Assessment Scale will be conducted to evaluate scars, comparing the two sites at two time points.

  5. Health-related quality of life

    Time frame: day 35 and 4-6 months

    A burn specific health-related quality of life assessment will be conducted and compared at two time points.

  6. Function

    Time frame: Day 3, 35 and 4-6 months

    The Patient Specific Function Scale assessment will be conducted and compared at three time points

Study contacts

Contact information is provided by the study sponsor or research team.

Kerriann Greenhalgh, Ph.D.

CONTACT

[email protected]

813-391-7722

Pam Sovine

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

KeriCure Medical

Industry

Collaborators

  • The University of Texas Health Science Center at San Antonio
  • United States Army Institute of Surgical Research
  • Valleywise Health

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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