An open, non-comparative, multicentre evaluation of performance and safety using an antimicrobial exudate transfer
K Dhatariya1, C Gooday1, B Franke2
1Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Colney Lane, Norwich United Kingdom.
Objective:
To evaluate the performance and safety of Mepilex Transfer Ag (MTAg) in the treatment of infected diabetic foot ulcers (DFU).
Method:
Patients with locally infected DFU were treated with the test dressing for up to 4 weeks, with a further 12 weeks of follow-up in a non-comparative study. Changes to wound infection and wound size as well as the condition of the peri-wound skin from baseline were assessed. Wound pain during dressing change was measured using a visual analogue scale (VAS). The investigators and patients documented their opinions on their overall experience of the test dressing and on key performance parameters.
Results:
Following treatment with the test dressing, the signs and symptoms of local wound infection present in the target DFU were substantially reduced compared with baseline. Following the posttreatment evaluation, the majority of the DFU exhibited no signs of infection. and mean wound size was reduced by 50%. Wound size also continued to steadily decrease during follow-up. At the end of treatment five DFUs were completely healed and a further six healed by the end of the follow-up period. Concomitantly, over the course of the study, wound exudate levels were reduced and there was a significant improvement in the condition of the peri-wound area. Wound pain at dressing change was low throughout; generally patients felt no anxiety during the dressing change procedure. The patients considered it a comfortable dressing that remained in place and allowed ease of movement during wear. The investigating clinicians were highly satisfied with the overall performance, especially with respect to its ease of application and removal, conformability and flexibility.
Conclusion:
This study has demonstrated the potential of the dressing to provide topical antimicrobial activity directly to an infected DFU, suggesting prompt treatment of an infected DFU with this topical antimicrobial could aid wound complications.
Declaration Of Interest:
The authors have no conflict of interest to declare.
