Field Shield Wound Dressing Study (NCT07337616) | Clinical Trial Compass
RecruitingNot Applicable
Field Shield Wound Dressing Study
United States40 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 feed…
What they're measuring
1
Wound closure
Timeframe: From enrollment to end of study, 4-6 months.