(CR-020) Clinical Evaluation of a Novel Silver Nano-Particulate Containing Wound Dressing for the Assessment of Biofilm and Infection

Graeme Kettlewell, PhD – Director of Research and Development, R&D, Speciality Fibres and Materials Ltd; Nyerngoor Korda Hewitt, Degree – Director of Regulatory Affairs and Quality, Regulatory Affairs and Quality, Speciality Fibres and Materials Ltd

Introduction: An observational clinical study was performed to collect data for a novel silver nano-particulate containing wound dressing. The study observed many variables including antimicrobial properties, achievement of treatment goals, maintenance of a moist wound environment, safety, and handling.

This is an ongoing study and early results for the antimicrobial properties of the dressing are presented here. The questions were: Is biofilm visible at the end of treatment? Did the dressing control infection? And did the dressing protect the wound from infection?

Methods: The study is an international, multicentre, single arm observational study with 36 patients and 7 users. Patients presented with various wounds: 1 patient had a second-degree burn, 12 had a ulcus cruris, 5 had a pressure ulcer, 3 had a diabetic ulcer, 10 had a postoperative wound, 3 had a traumatic wound and 2 had a wound with a high bleeding tendency. Patients were treated with the novel dressing made from sodium carboxymethyl cellulose and strengthening cellulose fibre with antimicrobial silver. Treatment time was 17.78 days on average. Biofilm determination was visually assessed before and after treatment by the user.

Results: A biofilm was visible in 22 out of 36 patients at the start of the study. After treatment no biofilm was visible in 12 of the 22 patients (55%), biofilm was partially visible in 8 patients (36%), and biofilm was visible in 2 patients (9%).

The users wanted to control infection in 17 of the 36 patients. It was reported that in 16 of the 17 patients (94%) the infection was controlled during treatment, and 1 patient in 17 (6%) was partially able to achieve this goal.

The users also wished to protect the wound from infection in 19 patients, and this goal was achieved in all 19 patients (100%).

Discussion: The application of a novel silver nano-particulate containing wound dressing successfully demonstrated the ability to reduce biofilm in this ongoing observational clinical study. The dressing was also able to successfully reduce signs of infection or remove infection altogether from the wound in all patients.