Field Shield Wound Dressing Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeriCure Medical
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Field Shield Wound Dressing
- Silverlon
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
KeriCure Medical
Lead sponsor
Valleywise Health
Collaborator
United States Army Institute of Surgical Research
Collaborator
The University of Texas Health Science Center at San Antonio
Collaborator
Source ClinicalTrials.gov