Clinical trial NCT02228122: The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Chronic Foot Wounds
Keywords: Chronic wounds
Biofilms
Bacteria
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
First posted: 2014-08-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.
timeFrame: up to day 28
Secondary outcomes:
measure: Size of the wound and an indicator of healing
timeFrame: up to day 28
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Diabetes Centre
Study officials:
affiliation: University of Manchester
name: Andrew J McBain, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Angela Oates, BSc, MSc, PhD, FIBMS
role: PRINCIPAL_INVESTIGATOR
References: