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| Name | Class |
|---|---|
| ConvaTec Inc. | INDUSTRY |
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The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms
Background: Chronic wounds and wound infections can be costly, resulting in prolonged hospital stays and an increased risk of secondary infection and septicaemia. In the UK the management of chronic venous leg ulcers is estimated to cost £1 billion/year, with surgical site infections requiring approximately 6.5 days additional hospital stay. Chronic wounds typically harbour a wide variety of bacteria; heavy bacterial colonisation and subsequent biofilm formation has been cited as a factor which induces a chronic inflammatory state and delays healing times.
AQUACEL®Ag+ Extra is a soft conformable flat sheet nonwoven fabric dressing, which forms a gel when it becomes wet. Its physical characteristics have the potential to increase the speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound bioburden. Removing these potential barriers to healing may help towards wound progression.
Aim: This is a pilot study to investigate the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms. Wound debridement tissue will be assessed for the presence/absence of in situ biofilms which will be monitored over 4 weeks and compared to the baseline (non-treatment) sample. Additionally, we will evaluate reductions in wound volume over the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquacel® Ag+ Extra | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquacel® Ag+ Extra | Device | Aquacel® Ag+ Extra dressing will be applied to wounds as per instructions for use, dressing to be changed at least one per week for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing. | Wound debridement tissue derived from standard of care will be retained for analysis up to Day 28. Tissue to be sectioned and analysed for the presence or absence of bacterial biofilms. | up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the wound and an indicator of healing | Weekly measurements of wound size | up to day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J McBain, BSc, PhD | University of Manchester | Principal Investigator |
| Angela Oates, BSc, MSc, PhD, FIBMS | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Diabetes Centre | Manchester | M13 0JE | United Kingdom |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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