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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-10-2-0159 | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| Criterium, Inc. | INDUSTRY |
| U.S. Army Medical Research and Development Command | FED |
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The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P6 Low Adherent Dressing | Experimental | All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). |
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| Standard of Care (SOC) | Active Comparator | All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P6 Low Adherent Dressing | Device | Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC). |
| Measure | Description | Time Frame |
|---|---|---|
| Management of skin grafts as determined by investigator's visual assessment of percent graft take | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-operative graft infections | 15 days | |
| Assessment of patient's pain / discomfort, using a visual analog scale. | 15 days | |
| Costs of study burn site wound dressing regimens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Cairns, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands at University of Florida | Gainesville | Florida | 32610 | United States | ||
| University of North Carolina, Chapel Hill |
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| Standard of Care (SOC) | Other | Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC). |
|
| 15 days |
| Ease of use and clinician preference of the study burn site wound dressing regimens | 15 days |
| Statistical robustness of visual graft take assessments in-person and from digital photographs | 15 days |
| Progression of percent graft take with time for both P6 and SOC. | 15 days |
| Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions. | 15 days |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Tennessee Firefighter's Regional Burn Center | Memphis | Tennessee | 38103 | United States |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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