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Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AQUACEL® | Active Comparator | A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC). |
|
| AQUACEL® Extra™ | Active Comparator | A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQUACEL® | Device | Dressing to be changed as clinically needed or at least every seven days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wear Time | frequency of dressing changes | 4 weeks |
| Wear Time | Reason for dressing changes | 4 weeks |
| % of dressings achieving a 7 day wear time | 4 weeks | |
| Time to achieve a 7 day wear time | 4 weeks | |
| Condition of the peri-ulcer skin | Improvement from baseline in the condition of the peri-ulcer skin | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith G Harding | Cardiff University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologische Gemeinschaftspraxis | Freiburg im Breisgau | 79100 | Germany | |||
| Bramfelder Chaussee |
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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 |
Dressing to be changed as clinically needed or at least every seven days. |
|
| Hamburg |
| Germany |
| Mitralis Expertise Centrum | Heerlen | 6401 CX | Netherlands |
| Nzoz Certus | Lodz | 90-553 | Poland |
| CF Centrum Flebologii Anna i Beata Narojczyk | Warsaw | 03-983 | Poland |
| Continuum Care | Warsaw | 18, 02-366 | Poland |
| Medyczna "Medservice" | Zabrze | 41-819 | Poland |
| Arrowe Park Hospital, | Upton | Wirral | CH49 5PE | United Kingdom |
| Bradford Teaching Hospitals | Bradford | BD9 6RJ | United Kingdom |
| Wound Healing Research Unit, Cardiff University | Cardiff | CF14 4XN | United Kingdom |
| Tissue Viability Consultancy Services Ltd | Eastbourne | BN21 4RL | United Kingdom |
| Walsall Healthcare NHS Trust Short Heath Clinic | Willenhall | WV12 5PR | United Kingdom |