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Due to lack of funding from the sponsor this study is being withdrawn.
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| Name | Class |
|---|---|
| Keraplast Technologies, LLC | UNKNOWN |
| Shriners Hospitals for Children | OTHER |
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The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.
Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keramatrix | Active Comparator | Keramatrix |
|
| Mepilex | Active Comparator | Mepilex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keramatrix | Device | Dressing for second degree burn |
| |
| Mepilex |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | Wound healing will be determined by measuring wound surface area. Wound surface area will be determined through planimetry, which will be performed on digital photographs of the wounds. | Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rates | Subjects will be monitored for unusual occurences, including signs and symptoms of infection. | Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals |
| Scarring |
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Inclusion Criteria:
patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Jimenez, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children | Galveston | Texas | 77551 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Device |
Dressing for second degree wound |
|
Scarring will be evaluated using the Vancouver Clinical Scar Scale. Assessments of graft pigmentation, vascularity, pliability and height will be performed at follow-up visits.
| 52 weeks up to 78 weeks |
| Pain | Pain will be assessed using pain scales according to age. | duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals, up to 3 times a week during dressing changes |