Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Valleywise Health | OTHER |
| United States Army Institute of Surgical Research | FED |
| The University of Texas Health Science Center at San Antonio | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSWD wound site | Experimental | One burn wound site on each participant will receive study treatment. |
|
| Control treatment | Active Comparator | One burn wound site on each patient receives standard treatment with silver dressing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Field Shield Wound Dressing | Device | Spray on wound dressing. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of study, 4-6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Rate of occurrence of infection per uint time. | 35 days |
| Surgical debridement | Rate of occurrence of surgical debridement and rate of occurrence of grafting |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerriann Greenhalgh, Ph.D. | Contact | 813-391-7722 | kgreenha@kericure.com | |
| Pam Sovine | Contact | Pam@kericure.com |
| Name | Affiliation | Role |
|---|---|---|
| Kerriann Greenhalgh, PH.D. | KeriCure Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valleywise Health | Recruiting | Phoenix | Arizona | 82008 | United States |
All collected de-identified IPD that underlie results in a publication.
January 1, 2027
Data will be submitted to the National Trauma Research Repository. Access will be limited to investigators with approved access.
Not provided
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
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.
Not provided
Not provided
Only the individual performing dressing changes will know which dressing is applied to which site. All others will be blinded.
| Silverlon |
| Device |
Silver dressing |
|
| 35 days |
| Pain severity | Pain will measured using a visual analog scale (0-10) at each dressing change comparing each site pain ratings. | 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. | 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. | day 35 and 4-6 months |
| Function | The Patient Specific Function Scale assessment will be conducted and compared at three time points | Day 3, 35 and 4-6 months |
| United State Army Institute of Surgical Research | Active, not recruiting | San Antonio | Texas | 78234 | United States |