To investigate the clinical performance and safety of a new silver-containing wound-contact layer, Physiotulle -Ag (Coloplast), in the treatment of chronic venous leg ulcers with delayed healing and signs of critical colonisation.
This was an open prospective non-comparative multicentre clinical study. Patients were treated for four weeks with Physiotulle -Ag, which was covered by Alione Hydrocapillary Dressing (Coloplast).
Thirty patients were recruited into the study. One ulcer healed after three weeks of treatment. The mean relative ulcer area reduced by 55% after four weeks. Over the study period the mean amount of healthy granulation tissue increased from 26% to 62%, and the mean amount of fibrin decreased from 63% to 32%. The ratio of malodorous wounds was 50% at inclusion, 20% after one week and 3% after four weeks. The dressing was considered easy or very easy to apply in 100% and easy to remove in 89% of dressing evaluations. The dressing combination showed good exudate-management properties. Incidence and severity of maceration, erythema and eczema decreased during the study and no device-related adverse events were recorded.
Physiotulle -Ag is safe and easy to use in chronic venous leg ulcers in which healing is delayed and with signs of critical colonisation.