Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07337616

Field Shield Wound Dressing Study

Led by KeriCure Medical · Updated on 2026-01-13

40

Participants Needed

2

Research Sites

73 weeks

Total Duration

On this page

Sponsors

K

KeriCure Medical

Lead Sponsor

V

Valleywise Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Field Shield Wound Dressing Study

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Thermal injury size 5-30% TBSA
  • Admitted to the burn center and enroll able within 72 hours of injury
  • Two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns that are comparable in depth
  • Subject or caregiver able and willing to follow protocol requirements
  • Ability to have wound photos and dressing change at 3 days
Not Eligible

You will not qualify if you...

  • Congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis
  • Undergoing hospice care
  • Currently being treated for an active malignant disease
  • Other conditions that may compromise subject safety as judged by the Investigator
  • Known allergies or contraindications to silver metals, silver chloride, silver tetraoxide, lidocaine, or dressing components
  • Burns on hands, feet, face, and/or genitals excluded from treatment sites
  • Combined TBSA of 31% or greater of partial and/or full thickness burn wounds
  • Participation in another clinical trial with an investigational drug or device that interferes with this study
  • Pregnant, breastfeeding, or planning to become pregnant
  • Recent or anticipated use of immunosuppressants, cytotoxic chemotherapy, or topical steroids
  • Previous treatment of study burn sites with tissue engineered or scaffold materials
  • Previous treatment of study burn sites with silvadene

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Valleywise Health

Phoenix, Arizona, United States, 82008

Actively Recruiting

2

United State Army Institute of Surgical Research

San Antonio, Texas, United States, 78234

Active, Not Recruiting

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Research Team

K

Kerriann Greenhalgh, Ph.D.

CONTACT

P

Pam Sovine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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