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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Field Shield Wound Dressing
DeviceSpray on wound dressing.
Silverlon
DeviceSilver dressing
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: FSWD wound siteExperimental treatment 1 intervention
Group B: Control treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wound closure
Wound closure will be assessed at each time point (day 3, 7, 12, 19, 28, 35). The probability of wound closure will be assessed with a cluster randomized Generalized Estimating Equations (GEE) model of the probability of closure in terms of treatment and clinical site with clustering by patient and login link.
Time frame
From enrollment to end of study, 4-6 months.Secondary outcomes
1
Infection
Rate of occurrence of infection per uint time.
Time frame
35 days2
Surgical debridement
Rate of occurrence of surgical debridement and rate of occurrence of grafting
Time frame
35 days3
Pain severity
Pain will measured using a visual analog scale (0-10) at each dressing change comparing each site pain ratings.
Time frame
days 3, 7, 12, 19, and 28.4
Scar
The Patient and Observer Scar Assessment Scale will be conducted to evaluate scars, comparing the two sites at two time points.
Time frame
day 35 and 4-6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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