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Clinical Research
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Dermacyn*: a novel superoxidized water facilitates wound healing. Early experience in lower extremity wounds and limb salvage David E. Allie, MD, Chris J. Hebert, RT, R-CIS, Mitchell D. Lirtzman, MD, Charles H. Wyatt, MD, V. Antoine Keller, MD, Adam A. Allie, MS, Craig M. Walker, MD Introduction: Between 220,000Ð240,000 lower extremity amputations (LEA) are performed yearly in the US and Europe secondary to diabetic foot ulcers (DFU), critical limb ischemia (CLI) and wound infection. Alarmingly, the mortality, morbidity and incidence of LEA is increasing with < 50% of amputees achieving full mobility. 80-85% of LEA are preceded by wounds and deeper infection and osteomyelitis undoubtedly play a major role in LEA. Interestingly, sparse recent data exists implicating infection in limb loss especially regarding local infection. DermacynTM is a stable pH neutral superoxidized solution with FDA approval for local antisepsis with intended use as a topical treatment for infected chronic and acute wounds. Significant antimicrobial activity has been demonstrated against spores, viruses (including HIV-1), and bacteria including pseudomonas aeruginosa, methicillin-resistant staphylococcus aureus (MRSA), and vancomycin-resistant Escherichia coli (VRE). The mechanisms of action include cellular protein denaturalization and cell wall lysis secondary to cellular osmotic pressure gradients and the hypotonic DermacynTM. DermacynTM (Oculus Innovative Sciences, Petaluma, CA) has been shown to be safe and non-toxic to normal cells, does not oxidize fibroblast DNA, and does not cause skin complications Methods: Between June 1 and December 1, 2005, 52 consecutive lower extremity wounds (CLI = 43, DFU = 5, CVI = 4) were treated with DermacynTM. A matched control group treated with traditional wound care (TWC) from the prior 6-months was retrospectively analyzed including time to wound healing (WH), limb salvage (LS), and wound treatment (TWC versus DermacynTM) Results: DermacynTM WH ranged from 12Ð81 days (mean = 31) and TWC WH from 20Ð123 days (mean = 64). The LS for DermacynTM and TWC were 51/52 (98.0%) and 48/52 (92.3%) respectively. There were no local DermacynTM complications. 7/52 (13.4%) TWC developed significant skin irritation Conclusion: DermacynTM facilitated WH in our initial 6-month experience therefore warranting a larger prospective randomized trial *DermacynTM Oculus Innovative Sciences, Petaluma, CA |
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