Recruiting

FSWD vs. Standard Dressing

Sponsor:

KeriCure Medical

Code:

NCT07337616

Conditions

Burn Wounds - Partial Thickness (2nd Degree)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Field Shield Wound Dressing

Silverlon

Study Details

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)

Study ID

NCT07337616

Start date

May 1, 2025

Status verified date

Jan, 2026

Completion date

Sep 29, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FSWD wound site

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

active comparator: Control treatment

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

Interventions

Field Shield Wound Dressing

Spray on wound dressing.

Silverlon

Silver dressing

Primary outcome measure

  • Wound closure [ Time Frame: From enrollment to end of study, 4-6 months. ]

Central Contacts and Locations

Central contacts

Kerriann Greenhalgh, Ph.D.

813-391-7722kgreenha@kericure.com

Pam Sovine

Pam@kericure.com

Locations

Valleywise Health

Recruiting

Phoenix, Arizona, United States, 82008

Contacts

Natalie Kesler, BSN

602-344-5726natalie.kesler@valleywisehealth.org

Principal Investigator:

Kevin Foster, MD

More Information

Sponsor

KeriCure Medical

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • FSWD
  • Burn wounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by KeriCure Medical on 2026-01-13.