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| Name | Class |
|---|---|
| B. Braun Medical SA | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prontosan wound irrigation solution | Experimental |
| |
| Standard care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prontosan wound irrigation solution | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of necrotic tissue (Pressure Sore Status Tool-PSST) | From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly) | |
| Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST) | From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of wound dressing (clinical score) | From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio | Busto Arsizio | Milan | Italy | |||
| Home nursing assistance |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012965 | Sodium Chloride |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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|
| Isotonic solution (saline or lactated ringer) | Drug |
|
|
| Florence |
| Italy |
| Policlinico San Matteo | Pavia | Italy |
| Azienda Ospedaliero-Universitaria Ospedali Riuniti | Trieste | Italy |
| Azienda Ospedaliero Universitaria San Giovanni Battista | Turin | Italy |
| Ospedale di Circolo-Fondazione Macchi | Varese | Italy |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |