Manchester Diabetes Centre
Manchester, M13 0JE, United Kingdom
NCT Number: NCT02228122
The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Manchester, M13 0JE, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to day 28
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.
Time frame: up to day 28
Weekly measurements of wound size
Dr Angela Oates
Other
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