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Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Urgo 3103166 | Experimental | Soft-adherent hydro-desloughing dressing |
|
| Device Aquacel Extra | Active Comparator | Hydrofibre dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgo 3103166 | Device | URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Relative regression of wound surface area | week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of debrided wounds | at each clinical evaluation up to 20 weeks | |
| Occurrence of adverse events as assessed by the investigator according to a classification MedDRA | between inclusion and week 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Meaume, MD | Contact | sylvie.meaume@rth.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sylvie Meaume, MD | Hospital Rothschild - Paris - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Rothschild | Recruiting | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Aquacel Extra | Device | Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated. |
|
| Patient's Quality of Life | at inclusion visit and at week 20 or at the end of study treatment |