The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms

Study Overview
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Brief Summary
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The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms

Detailed Description
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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.

Conditions
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Diabetes, Chronic Foot Wounds

Intervention / Treatment
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* Device: Aquacel® Ag+ Extra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provided written informed consent Be over 18 years of age Must have a chronic foot wound greater than 4 weeks in duration Be willing and able to attend the clinic for the required study visits - Exclusion Criteria: Subjects with a history of sensitivity to any one of the components of the device being studied Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study Subjects who are currently participating in or have been on a clinical study within the last 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquacel® Ag+ Extra<br> | Device: Aquacel® Ag+ Extra<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of the wound and an indicator of healing | Weekly measurements of wound size | up to day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic wounds, Biofilms, Bacteria