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® 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.

Keywords

Dabetic Foot Ulceration Infection Antiseptic solutions Local care.

Get full access to this article

View all access options for this article.

References

Boulton AJ Clinical presentation and management of diabetic neuropathy and foot ulceration . Diabet Med. 1991;8:S52-S57.

Caputo GM , Cavanagh PR , Ulbrecht JS , Gibbons GW , Karchmer AW Assessment and management of foot disease in patients with diabetes. N Engl J Med. 1994;331:854-860.

Aragon-Sanchez FJ , Cabrera-Galvan JJ , Quintana-Marrero Y. , et al. Outcomes of a surgical treatment of diabetic foot osteomyelitis: a series of 185 patients with histopathological confirmation of bone involvement. Diabetologia. 2008;51:1962-1970.

Lipsky BA , Pecoraro RE , Wheat LJ The diabetic foot. Soft tissue and bone infection. Infect Dis Clin North Am. 1990;4:409-432.

Tanaka H. , Hirakata Y. , Kaku M. , et al. Antimicrobial activity of superoxidized water. J Hosp Infect. 1996;34:43-49.

Venkitanarayanan KS , Ezeike GO , Hung YC , Doyle MP Efficacy of electrolyzed oxidizing water for inactivating Escherichia coli O157:H7, Salmonella enteritidis, and Listeria monocytogenes. Appl Environ Microbiol. 1999 ;65:4276-4279.

Yahagi N. , Kono M. , Kitahara M. , et al. Effect of electrolyzed water on wound healing. Artif Organs. 2000;24:984-987.

Bill TJ , Ratliff CR , Donovan AM , Knox LK , Morgan RF , Rodeheaver GT Quantitative swab culture versus tissue biopsy: a comparison in chronic wounds . Ostomy Wound Manage. 2001;47:34-37.

Ratliff C. , Rodeheaver G. Correlation of semi-quantitative swab cultures to quantitative swab cultures from chronic wounds. Wounds. 2002;14:329-333.

10.

Goretti C. , Mazzurco S. , Ambrosini Nobili L. , et al. Clinical outcomes of wide postsurgical lesions in the infected diabetic foot managed with 2 different local treatment regimes compared using a quasi-experimental study design: a preliminary communication. Int J Low Extrem Wounds. 2007;6:22-27.

11.

Piaggesi A. , Macchiarini S. , Rizzo L. , et al. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. Diabetes Care. 2007;30:586-590.

12.

Eckman MH , Greenfield S. , Mackey WC , et al. Foot infections in diabetic patients. Decsion and cost-effectiveness analyses. JAMA. 1995;273:712-720.

13.

Lipsky BA Evidence-based antibiotic therapy of diabetic foot infections. FEMS Immunol Med Microbiol. 1999;26:267-276.

14.

Sampson MN , Muir AV Not all the super-oxidized waters are the same. J Hosp Infect . 2002;52:228-229.

15.

Landa-Solis M. , Gonzalez-Espinosa D. , Guzman B. , et al. Microcyn™, a novel super-oxidized water with neutral pH and disinfectant activity. J Hosp Infect. 2005;61:291-299.

16.

Ohno H. , Higashidate M. , Yokosuka T. Mediastinal irrigation with superoxidized water after open-heart surgery: the safety and pitfalls of cardiovascular surgical application. Surg Today. 2000;30:1055-1056.

17.

Prompers L. , Schaper N. , Apelqvist J. , et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008;5:747-755.

18.

Joseph WS , LeFrock JL The pathogenesis of diabetic foot infections-immunopathy, angiopathy, and neuropathy. J Foot Surg. 1987;26(1 suppl):S7-S11.

19.

Bagdade JD , Root RK , Bulger RJ Impaired leukocyte function in patients with poorly controlled diabetes. Diabetes. 1974;23:9-16.

20.

Repine JE , Clawson CC , Goetz FE Bactericidal function of neutrophils from patients with acute bacterial infections and from diabetes. J Infect Dis. 1980;142:869-872.

21.

Katz S. , Klein B. , Elian I. , et al. Phagocyte activity of monocytes from diabetic patients. Diabetes Care. 1983;6:479-485.

22.

Wheat LJ , Allen SD , Henry M. , et al. Diabetic foot infections. Bacteriological analysis. Arch Intern Med. 1986;146: 1935-1939.

23.

Joshi N. , Caputo GM , Weitekamp MR , Karchmer AW Infections in patients with diabetes mellitus. N Engl J Med . 1999;34: 1906-1912.

24.

LeFrock JL , Joseph WS Bone and soft-tissue infections of the lower extremity in diabetics. Clin Podiatr Med Surg. 1995;12: 87-103.

25.

Lew DP , Waldvogel FA Osteomyelitis. N Engl J Med. 1997; 336:999-1007.

26.

Panuncialman J. , Falanga V. The science of wound bed preparation. Clin Plast Surg. 2007;34:621-632.

27.

Jeffcoate WJ , Price P. , Harding KG; International Working Group on Wound Healing and Treatments for People with Diabetic Foot Ulcers. Wound healing and treatments for people with diabetic foot ulcers. Diabetes Metab Res Rev. 2004;20(suppl 1):S78-S89.

28.

Piaggesi A. , Schipani E. , Campi F. , et al. Conservative surgical approach versus non-surgical management for diabetic neuropathic foot ulcers: a randomized trial. Diabet Med. 1998;15: 412-417.

29.

Aragon-Sanchez FJ , Lazaro-Martinez JL , Quintana-Marrero Y. , et al. Are diabetic foot ulcers complicated by MRSA osteomyelitis associated with a worse prognosis? Outcome of a surgical series. Diabet Med . 2009;26:552-555.

30.

Lewis SB , Biondo CF , Page JC Medical management of the diabetic patient during podiatric surgery. J Am Podiatr Med Assoc. 1994;84:432-438.

31.

Eckman MH , Greenfield S. , Mackey WC , et al. Foot infections in diabetic patients. Decision and cost-effectiveness analyses. JAMA. 1995;273:712-720.

32.

Prompers L. , Huijberts M. , Schper N. , et al. Resource utilisation and costs associated with the treatment of diabetic foot ulcers. Prospective data from the Eurodiale Study. Diabetologia. 2008;51:1826-1834.