The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms
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|ClinicalTrials.gov Identifier: NCT02228122|
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Chronic Foot Wounds||Device: Aquacel® Ag+ Extra||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
|Experimental: Aquacel® Ag+ Extra||
Device: Aquacel® Ag+ Extra
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.
- A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing. [ 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.
- Size of the wound and an indicator of healing [ Time Frame: up to day 28 ]Weekly measurements of wound size
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228122
|Manchester Diabetes Centre|
|Manchester, United Kingdom, M13 0JE|
|Principal Investigator:||Andrew J McBain, BSc, PhD||University of Manchester|
|Principal Investigator:||Angela Oates, BSc, MSc, PhD, FIBMS||University of Manchester|