Clinical efficacy of a silver-releasing foam dressing in venous leg ulcer healing: a randomised controlled trial

摘要

Biatain and Biatain-Ag are two identical wound dressings except the fact that Biatain-Ag releases silver. In the present multinational double-blinded randomised controlled trial the effect of the two dressings were compared for treatment of venous leg ulcers. A total of 181 patients were treated for 6 weeks with either Biatain or Biatain-Ag followed by 4 weeks treatment with Biatain. Biatain-Ag showed superior performance in relative wound area reduction after 6 weeks treatment and the estimated treatment difference increased after 10 weeks indicating that the effect of silver continues at least for 4 weeks after treatment. A subgroup of the patients differed significantly from the others with respect to parameters associated with a poor healing prognosis; patients were older, had significant history of venous thrombosis, larger ulcers with longer duration and more often recurrent. For this subgroup of patients Biatain-Ag showed significant (P < 005) better performance in terms of relative ulcer area reduction and healing rate. In conclusion, this study suggests the superior performance of Biatain-Ag compared with the non silver-releasing dressing Biatain in particular for patients having ulcers associated with a poor healing prognosis.