The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many bacteria are present in infected wounds over an 8 week period.
The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many bacteria are present in infected wounds over an 8 week period. DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing for use on a variety of exuding wounds and is widely used in routine clinical practice within the UK. The primary outcome will be the quantitative reduction in bacterial load, based on a wound biopsy, from baseline to week 8. Secondary objectives will include the quantitative reduction in bacterial load, based on biopsy, from initial assessment to week 4, and the semi-quantitative reduction in bacterial load, based on swab analysis, from baseline to weeks 4 and 8. Additionally dressing performance measures will be assessed as well as all adverse events and device deficiencies. In total 20 evaluable participants with an infected venous leg ulcer will be recruited into the trial. All participants will have their wound dressed using DURAFIBER Ag and will be followed-up for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing
Hull & East Riding Hospitals NHS Trust
Hull, East Yorkshire, United Kingdom
Lancashire Care NHS Foundation Trust
Preston, Lancashire, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom
Cardiff & Vale University Healthcare Board
Cardiff, Wales, United Kingdom
Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8
Time frame: 8 weeks
Change in the mean log10 bacterial count from tissue biopsies from baseline to week 4.
Time frame: 4 weeks
The semi-quantitative presence of bacteria, bacteria type and species from the weekly swabs
Time frame: 8 weeks
Change in the number of subjects showing clinical signs of infection from baseline to weeks 4 and 8.
Time frame: 8 weeks
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Northumbria Healthcare NHS Foundation Trust
Ashington, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom