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| Name | Class |
|---|---|
| Artsana S.p.a. | INDUSTRY |
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Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and patient's pain.
In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the Pressure Sore Status Tool(PSST).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MySkin patch | Experimental | Hydrogel and polyurethane film |
|
| Traditional Dressing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MySkin patch | Device | Hydrogel and polyurethane film |
| |
| Gauze and Patch |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | 1 month | |
| Patient's pain | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of the lesion scores for each visit | 1 month | |
| The presence / absence of infection for each visit | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tommaso Bianchi | Associazione Infermieristica per lo studio delle Lesioni Cutanee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Bellaria - UOC Dermatologia | Bologna | Bologna | 40100 | Italy |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Device |
Traditional Dressing |
|