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.
To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Spray on wound dressing.
Silver dressing
Valleywise Health
Phoenix, Arizona, United States
RECRUITINGUnited State Army Institute of Surgical Research
San Antonio, Texas, United States
ACTIVE_NOT_RECRUITINGWound 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.
Infection
Rate of occurrence of infection per uint time.
Time frame: 35 days
Surgical debridement
Rate of occurrence of surgical debridement and rate of occurrence of grafting
Time frame: 35 days
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.
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 months
Health-related quality of life
A burn specific health-related quality of life assessment will be conducted and compared at two time points.
Time frame: day 35 and 4-6 months
Function
The Patient Specific Function Scale assessment will be conducted and compared at three time points
Time frame: Day 3, 35 and 4-6 months
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