title: 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.
abstract: This randomized trial was done to test the effectiveness and safety of using a novel antiseptic solution (Dermacyn(R) 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 randomized into 2 groups. Group A was locally treated with DWC, whereas group B received povidone iodine as local medication, 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.
authors.affiliation: Department of Endocrinology and Metabolism Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. piaggesi@immr.med.unipi.it
authors.forename: A
authors.initials: A
authors.lastname: Piaggesi
authors.forename: C
authors.initials: C
authors.lastname: Goretti
authors.forename: S
authors.initials: S
authors.lastname: Mazzurco
authors.forename: C
authors.initials: C
authors.lastname: Tascini
authors.forename: A
authors.initials: A
authors.lastname: Leonildi
authors.forename: L
authors.initials: L
authors.lastname: Rizzo
authors.forename: A
authors.initials: A
authors.lastname: Tedeschi
authors.forename: G
authors.initials: G
authors.lastname: Gemignani
authors.forename: F
authors.initials: F
authors.lastname: Menichetti
authors.forename: S
authors.initials: S
authors.lastname: Del Prato
mesh_terms: D000368:Aged; D000891:Anti-Infective Agents, Local / Q000494:pharmacology / Q000627:therapeutic use*; D015169:Colony Count, Microbial; D003646:Debridement; D017719:Diabetic Foot / Q000150:complications / Q000601:surgery; D005500:Follow-Up Studies; D006801:Humans; D006861:Hydrogen Peroxide / Q000494:pharmacology / Q000627:therapeutic use*; D017053:Infection Control; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D011182:Postoperative Care; D011206:Povidone-Iodine / Q000627:therapeutic use; D012008:Recurrence; D012449:Safety; D017592:Skin Care / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*; D014946:Wound Infection / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000891:Anti-Infective Agents, Local; C118085:superoxidized water; D011206:Povidone-Iodine; D006861:Hydrogen Peroxide