Actively Recruiting
Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds
Led by KeriCure Medical · Updated on 2026-01-13
40
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
K
KeriCure Medical
Lead Sponsor
V
Valleywise Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Field Shield Wound Dressing (FSWD) as a treatment for partial thickness burn wounds, comparing it to a standard silver dressing. The study aims to assess healing, infection rates, pain or discomfort, and whether the wound deepens over time in patients with burns covering 5-30% of their total body surface area. This is an interventional trial sponsored by KeriCure Medical with a focus on improving burn wound care outcomes. Participants will have two separate burn wound sites treated: one with the Field Shield Wound Dressing applied as a spray, and the other with the standard silver dressing called Silverlon. The study follows a randomized, double-blind design where each participant receives both treatments on different wound areas. Dressing changes and visual assessments will be conducted regularly to evaluate the effects of each dressing. During the study, participants will undergo dressing changes, wound photography at day 3, and monitoring for wound closure over 4 to 6 months. Researchers will measure infection rates, need for surgical removal of damaged tissue, pain severity at multiple time points, scar formation, quality of life, and physical function throughout the study period. Safety and healing progress will be closely tracked to understand how both dressings perform in treating large surface area burn wounds.
CONDITIONS
Brief Title
Field Shield Wound Dressing Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Thermal injury size 5-30% total body surface area (TBSA)
- Admitted to the burn center and able to enroll within 72 hours of injury
- Two distinct burn areas of 100 cm² or larger each, judged to be comparable in depth
- Participant or caregiver able and willing to follow protocol requirements
- Able to have wound photos and dressing change at 3 days
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 treated for an active malignant disease
- Other conditions compromising safety as judged by the Investigator
- Known allergies or contraindications to silver metals, silver chloride, silver tetraoxide, lidocaine, silicone, or adhesives used in dressings
- Burns on hands, feet, face, or genitals excluded from treatment sites but included in total TBSA
- Combined TBSA of 31% or greater partial/full thickness burns
- Participation in another clinical trial with investigational drug or device that interferes
- Pregnant, breastfeeding, or planning pregnancy
- Recent or planned use of immunosuppressants, chemotherapy, or topical steroids
- Burn sites previously treated with tissue engineered or scaffold materials
- Burn sites previously treated with silvadene
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive treatment with the Field Shield wound dressing or standard silver dressing on separate burn wound sites.
Dressing changes and visual assessments occur at days 3, 7, 12, 19, 28, and day 35
Duration - Up to 6 months
Participants are monitored for wound closure, infection, pain severity, scar development, quality of life, and function.
Assessments at day 35 and between 4 to 6 months
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
Research Team
K
Kerriann Greenhalgh, Ph.D.
P
Pam Sovine
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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