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

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228122
• Other study ID #: UoM Study REF: 14118
• Status: Completed
• Phase: N/A
• First received: August 26, 2014
• Last updated: December 1, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Foot Wounds
• Diabetes

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Manchester Diabetes Centre	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Dr Angela Oates	ConvaTec Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Size of the wound and an indicator of healing	Weekly measurements of wound size	up to day 28	No