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

Dr Angela Oates

Status: Completed

Conditions: Diabetes; Chronic Foot Wounds

Treatments: Device: Aquacel® Ag+ Extra

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02228122

UoM Study REF: 14118

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Aquacel® Ag+ Extra

Experimental group

Treatment:

Device: Aquacel® Ag+ Extra