ULURU Inc. (NYSE Alternext: ULU) announced today the presentation of results from the first completed randomized clinical trial for Altrazeal at the SAWC Fall symposium in Washington D.C. September 16-18. The recently completed clinical study compared healing, pain and comfort of skin graft donor sites treated with either Altrazeal(TM) or with a leading commercial sodium carboxymethylcellulose-silver ("CMC-Ag") dressing.
Major results from the study indicated that there was a significant difference in patient's pain scores, all favoring Altrazeal with lower pain scores at each time point (p<0.0001). When asked about the comfort of the wound dressing at the edges, these subjects found Altrazeal to be more comfortable (p<0.001) and less painful when the dressing came in contact with clothes or bedding (p<0.001). The study endpoints validated the hypothesis for time to healing for both dressings in this particular type of acute surgical wound.
The study was a single-center, prospective randomized trial in which each patient served as his/her own control. Each patient had at least two split-thickness donor sites of which one was dressed with Altrazeal(TM) and the other one with the CMC-Ag dressing.
Renaat Van den Hooff, President and CEO of ULURU Inc., commented: "We are extremely delighted with the results of this clinical trial. Skin graft donor sites are an acute wound that typically heals without any complications, so we expected to show little difference in healing. Nonetheless, these type of surgical wounds are nearly always extremely painful to the patient and to show statistical significance in pain and patient comfort versus a well recognized leading global brand confirms the attributes of Altrazeal(TM) and its promising future."
In addition to the randomized clinical trial, more clinical evidence on the treatment of various wound types using Altrazeal(TM) Transforming Powder Dressing will be presented on multiple posters during the symposium.