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

Not Applicable

Completed

• Conditions: Chronic Foot Wounds; Diabetes
• Interventions: Device: Aquacel® Ag+ Extra

• Registration Number: NCT02228122
• Lead Sponsor: Dr Angela Oates

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-28
• Study Start: 2014-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aquacel® Ag+ Extra	Aquacel® Ag+ Extra	-

Primary Outcome Measures

Name	Time	Method
A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.	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.

Secondary Outcome Measures

Name	Time	Method
Size of the wound and an indicator of healing	up to day 28	Weekly measurements of wound size

Trial Locations

Locations (1)

Manchester Diabetes Centre; 🇬🇧 Manchester, United Kingdom