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The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to manage bioburden in leg ulcers over a two week study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquacel® Ag | Active Comparator |
| |
| Mepilex® Border Ag | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquacel® Ag | Device | Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate. |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial load reduction | The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods. | Days 1 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical evolution of the wound (presence of each of the selected clinical signs) | Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour | Days 1, 3, 7, 14 |
| Occurrence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Harding | Cardiff University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Willows Centre for Health Care | Weaste | Salford | M5 2JR | United Kingdom | ||
| Wound Healing Research Unit, Cardiff University |
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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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| Mepilex® Border Ag | Device | Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate. |
|
| Day 1-14 |
| Cardiff |
| Wales |
| CF14 4XN |
| United Kingdom |
| Arrowe Park Hospital | Upton | Wirral | CH49 5PE | United Kingdom |