A Randomized Controlled Trial to Examine the Efficacy and Safety of a New Super-Oxidized Solution for the Management of Wide Postsurgical Lesions of the Diabetic Foot

This randomized trial was done to test the effectiveness and safety of using a novel antiseptic solution (Dermacyn ® Wound Care [DWC], Oculus Innovative Sciences, Petaluma, CA) in the management of the postoperative lesions on the infected diabetic foot. 40 patients with postsurgical lesions wider than 5 cm2 left open to heal by secondary intention were ran-domized into 2 groups. Group A was locally treated with DWC, whereas group B received povidone iodine as local medi-cation, both in adjunct to systemic antibiotic therapy and surgical debridement if needed. Ischemia, renal failure, bilateral lesions, or immunodepression were considered as exclusion criteria. Patients were followed up weekly for 6 months. The primary endpoint was healing rate at 6 months, while secondary endpoints were healing time, time to achieve negative cultures, duration of antibiotic therapy, number of reinterventions, and adverse events. Healing rates at 6 months were significantly shorter in group A (90%) than in group B (55%; P <.01). The time taken for cultures to become negative and duration of antibiotic therapy were also significantly (P <.05) shorter in group A than in group B, whereas the number of reinterventions was significantly higher in group B (P <.05). No difference was noted in the adverse events except that for reinfections, which were more frequent in group B than in group A (P <.01). DWC is as safe as and more effective than standard local antiseptics in the management of wide postsurgical lesions in the infected diabetic foot