Burn Wounds - Partial Thickness (2nd Degree)
Conditions
Keywords
FSWD, Burn wounds
Brief 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.
Detailed description
To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.
Interventions
DEVICEField Shield Wound Dressing
Spray on wound dressing.
DEVICESilverlon
Silver dressing
Sponsors
Valleywise Health
United States Army Institute of Surgical Research
The University of Texas Health Science Center at San Antonio
KeriCure Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Only the individual performing dressing changes will know which dressing is applied to which site. All others will be blinded.
Intervention model description
In this study each subject will serve as their own control receiving the intervention dressing on one wound and the standard of care dressing on another wound.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 feeding, or planning to become pregnant. * Subjects who, within 60 days prior to enrollment, have a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, application of topical steroids within one month prior to enrollment, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. * Burn study site(s) has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) preceding the study wound dressing application. * Burn study site(s) has been previously treated with a silvadene
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound closure | From enrollment to end of study, 4-6 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical debridement | 35 days | Rate of occurrence of surgical debridement and rate of occurrence of grafting |
| Pain severity | days 3, 7, 12, 19, and 28. | Pain will measured using a visual analog scale (0-10) at each dressing change comparing each site pain ratings. |
| Infection | 35 days | Rate of occurrence of infection per uint time. |
| Health-related quality of life | day 35 and 4-6 months | A burn specific health-related quality of life assessment will be conducted and compared at two time points. |
| Function | Day 3, 35 and 4-6 months | The Patient Specific Function Scale assessment will be conducted and compared at three time points |
| Scar | day 35 and 4-6 months | The Patient and Observer Scar Assessment Scale will be conducted to evaluate scars, comparing the two sites at two time points. |
Countries
United States
Contacts
Primary ContactKerriann Greenhalgh, Ph.D.
Backup ContactPam Sovine
Outcome results
None listed