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| Name | Class |
|---|---|
| Innovatech Engineering, LLC | UNKNOWN |
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This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Ag | Active Comparator | patient will receive Mepilex Ag for their site, standard of care to be followed. |
|
| Xeroform | Active Comparator | patient will receive Xeroform for their site, standard of care to be followed. |
|
| NovaDress | Experimental | patient will receive NovaDress for their site, standard of care to be followed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaDress | Device | NovaDress is constructed of pure cellulose derived from tree pulp. The tree pulp is reconstructed into hydrated sheets wrapped in nonwoven viscose and irradiated. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Healing | To compare and healing (defined as >95% epithelization) at the study donor sites treated with a cellulose dressing to two standard of care dressings- an antimicrobial foam dressing and a bacteriostatic petrolatum based gauze dressing. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absorbent ability | Ability of dressing to absorb exudate measured by staff satisfaction survey | 14 days |
| Conformability | Ability of dressing to maintain shape measured by staff satisfaction survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Still Research Foundation | Augusta | Georgia | 30909 | United States |
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| Mepilex Ag | Device | Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. |
|
| Xeroform | Device | Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate. |
|
| 14 days |
| Adherence | Ability of dressing to remain fixed in place measured by staff satisfaction survey | 14 days |
| Management of bloody exudate | Ability of dressing to absorb bloody exudate measured by staff satisfaction survey | 14 days |
| Ease of removal | Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey | 14 days |
| Cost | Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey | 14 days |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 7, 2023 | Mar 31, 2023 | 1 | ||
| Sep 26, 2023 | Oct 20, 2023 | 2 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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