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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.
Int J Low Extrem Wounds 2010; 9(1):10-5IJ

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+Show Affiliations

Department of Endocrinology and Metabolism Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. piaggesi@immr.med.unipi.it

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20207618

Citation

Piaggesi, A, et al. "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." The International Journal of Lower Extremity Wounds, vol. 9, no. 1, 2010, pp. 10-5.
Piaggesi A, Goretti C, Mazzurco S, et al. 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. Int J Low Extrem Wounds. 2010;9(1):10-5.
Piaggesi, A., Goretti, C., Mazzurco, S., Tascini, C., Leonildi, A., Rizzo, L., ... Del Prato, S. (2010). 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. The International Journal of Lower Extremity Wounds, 9(1), pp. 10-5. doi:10.1177/1534734610361945.
Piaggesi A, et al. 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. Int J Low Extrem Wounds. 2010;9(1):10-5. PubMed PMID: 20207618.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Piaggesi,A, AU - Goretti,C, AU - Mazzurco,S, AU - Tascini,C, AU - Leonildi,A, AU - Rizzo,L, AU - Tedeschi,A, AU - Gemignani,G, AU - Menichetti,F, AU - Del Prato,S, PY - 2010/3/9/entrez PY - 2010/3/9/pubmed PY - 2010/6/11/medline SP - 10 EP - 5 JF - The international journal of lower extremity wounds JO - Int J Low Extrem Wounds VL - 9 IS - 1 N2 - 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. SN - 1552-6941 UR - https://www.unboundmedicine.com/medline/citation/20207618/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_ L2 - http://journals.sagepub.com/doi/full/10.1177/1534734610361945?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -