Field Shield Wound Dressing
DeviceSpray on wound dressing.
NCT Number: NCT07337616
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Valleywise Health, Phoenix, Arizona, United States
To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spray on wound dressing.
Silver dressing
Time frame: 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.
Time frame: 35 days
Rate of occurrence of infection per uint time.
Time frame: 35 days
Rate of occurrence of surgical debridement and rate of occurrence of grafting
Time frame: 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.
Time frame: 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.
Time frame: day 35 and 4-6 months
A burn specific health-related quality of life assessment will be conducted and compared at two time points.
Time frame: Day 3, 35 and 4-6 months
The Patient Specific Function Scale assessment will be conducted and compared at three time points
Contact information is provided by the study sponsor or research team.
Kerriann Greenhalgh, Ph.D.
CONTACT
Pam Sovine
CONTACT
KeriCure Medical
Industry
Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07025408
Burn, Burn Wounds - Partial Thickness (2nd Degree)
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT00343824
Burn Wounds - Partial Thickness (2nd Degree)
Ghent, Belgium
View Trial DetailsNCT06857435
Burns, Contracture Scar
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06857448
Burns, Contracture Scar
Pittsburgh, Pennsylvania, United States
View Trial Details