(PRNewswire) Alliqua has announced interim results from a post-marketing pilot study to investigate the reduction in scarring and incidence of infection conferred by Alliqua's SilverSeal dressing, compared to that of a standard petroleum-based dressing in patients who had undergone foot and ankle surgery. Preliminary results at four weeks show reduced incidence of infection as well as a greater reduction in scar length, width and height among patients using SilverSeal, compared to those who had the control dressing applied.
Study results are being presented at the annual meeting of the American College of Foot and Ankle Surgeons. In this study 62 patients who had undergone ankle and foot (including forefoot, midfoot or hindfoot) surgery were randomized 1:1 to receive either Alliqua's silver-impregnated SilverSeal dressing or a standard petroleum-based dressing. Following surgery, all patients were evaluated for three months following surgery to assess degree of scarring, the presence of superficial or deep infections, and dehiscence (the re-opening of surgical wounds).
At four weeks, 30 patients had been assessed for infection and dehiscence. In these preliminary results, there were no cases of post-operative infection reported in the 15 patients who received the SilverSeal@ dressing and three infections in patients who received the petroleum-based dressing. Moreover, none of the SilverSeal@ patients experienced dehiscence. At the time of the data submission, complete scar metrics were available for eight patients. Among these eight, those in the SilverSeal@ group experienced greater reductions in average scar length, width and height compared to those patients with petroleum-based dressings. Complete results from the entire study population will be presented at a future medical meeting.
These results are summarized in a poster titled "Utilization of Silver Hydrogel Sheet Dressing on Post-Surgical Wounds: A Pilot Study in Foot & Ankle Surgery" that is being presented at the ACFAS meeting.