Chronic Foot Wounds, Diabetes
Conditions
Keywords
Chronic wounds, Biofilms, Bacteria
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.
Interventions
DEVICEAquacel® 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.
Sponsors
ConvaTec Inc.
Dr Angela Oates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Size of the wound and an indicator of healing | up to day 28 | Weekly measurements of wound size |
Countries
United Kingdom
Outcome results
None listed