Super-Oxidized Solution (SOS) Therapy for Infected Diabetic Foot Ulcers

  • 8/31/2006
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Author(s): 
Luca Dalla Paola, MD; Enrico Brocco, MD; Antonella Senesi, MD, PhD; Maurizio Merico, MD; Daniele De Vido, MD; Roberta Assaloni, MD; Roberto DaRos, MD

Chronic wounds are a great burden to the healthcare system and account for approximately $20 billion in healthcare costs annually in the United States.1 Foot ulceration is the precursor to approximately 85% of all diabetic amputations, and it is estimated that 14%–20% of patients with foot ulcers will have to undergo amputation.2 Infection of the ulcer increases the risk of amputation.3 If patients with ulcers are initially treated by a multidisciplinary team, major amputations can be prevented in 80%–90% of cases of limb-threatening ischemia and in 95% of patients with infection.4–7 This is significant, because amputations are related to high morbidity and mortality, costing up to $60,000 per patient.8,9
The most widely used therapies for treating foot ulcers are operative procedures and systemic antibiotics, highlighting the importance of infection control.10–13 Topical antiseptics are used to reduce the microbial load in both intact skin and in wounds, but their role in the treatment of diabetic foot ulcers has yet to be determined.14 Antiseptics have been used in preference to topical antibiotics because of concerns about the development of bacterial resistance. However, the cytotoxic effects of these agents on the host’s dermal and epidermal cells may affect the wound healing process.15
Super-oxidized solutions may represent an alternative to the currently available antiseptics for the disinfection of skin and wounds.16–19 These solutions are electrochemically processed aqueous solutions manufactured from pure water and sodium chloride (NaCl). During the electrolysis process, water molecules are pulled apart, and reactive species of chlorine and oxygen are formed.20 Different super-oxidized solutions have different properties.21 Increased acidity or alkalinity and high concentrations (> 100 ppm) of free available chlorine (FAC) correlate with increased corrosiveness and toxicity of a solution. Another problem with these solutions has been stability, which can range from a few hours to several days.
Recently, a neutral pH super-oxidized solution (SOS; Dermacyn® Wound Care, Petaluma, Calif, USA) became available in Europe. According to the manufacturer, this solution has a low FAC (< 80 ppm) and is stable for more than 1 year. This solution has shown broad antimicrobial activity even against antibiotic-resistant strains.20,22 It has also been reported that this solution does not induce skin, dermal, or systemic toxicities in animal models.20 Preliminary data in humans also suggest efficacy and safety.23,24
To evaluate the role of this novel solution in infected diabetic foot lesions, the authors compared SOS with 10% povidone iodine solution (PI) as the adjuvant local antimicrobial therapy in a standard treatment program. The program included operative procedures, systemic antibiotic therapy, and offloading techniques.
The main objective was to evaluate the reduction in the number of bacterial species during the course of treatment. Other variables evaluated included the time to lesion healing, the incidence and types of operative outcomes, and adverse events.

References: 

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