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Clinical Research
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Evaluation of the clinical effectiveness of a collagen-ORC antimicrobial matrix in neuropathic diabetic ulcers Robert Snyder, DPM, J.R. Hanft, Doctors Research Network, South Miami, FL; T. Serena, Penn North Center for Advance Wound Care, Warren, PA Collagen-ORC Antimicrobial Matrix (CAM) is a sterile, freeze-dried composite of 44% oxidized regenerated cellulose (ORC) and 55% collagen, combined with 1% silver-ORC (0.24% silver). Collagen-ORC composites have been shown in vitro to bind wound fluid constituents that interfere with wound healing (eg, Matrix Metalloproteases) and CAM has been shown to have in vitro bactericidal activity against common wound pathogens without detrimental effect in host cell (fibroblast) proliferation assays. This abstract will report the results of a randomized, prospective, open-label, multicenter, comparative trial of 45 subjects enrolled at three centers between June 2004 and November 2005, randomized to receive either CAM or moist wound healing until wound closure or 12 weeks, whichever occurred first. All enrolled subjects had a Wagner Grade I or II ulcer of >1 but <10 cm2 in area, ABI >0.8, Hgb A1C < 9.1 and were free of clinical signs of infection. Subjects had a 3 to 7 day run-in period before randomization. Wounds were debrided of all non-viable tissue, photographed, measured (planimetry) and wound biopsies obtained for culture prior to randomization. Weekly planimetry, photographs, and clinical evaluations were obtained of all study wounds. Subjects received standardized off-loading footwear for the duration of the study and twin pedometers (waist and boot) were used to monitor use of boots during ambulation. Primary endpoint was reduction in wound area at 12 weeks and secondary outcomes included the rate of wound closure, incidence of infection, QoL and ease of dressing use. Baseline quantitative culture results will also be correlated to clinically observed wound characteristics and reduction in wound area Enrollment in the trial has been completed, but the final visits are pending at this time. Complete data will be available at the time of presentation Expanded version may be presented at the Research Forum. Vin F, Teot L, Meaume S. The healing properties of Promogran in venous leg ulcers. J Wound Care. 2002;11(9):335Ð341 Cullen B, Watt PW, Lundquist C, et al. The role of oxidized regenerated cellulose/collagen in chronic wound repair and its potential mechanism of action. J Biochem Cell Biol. 2002;34(12):1544Ð1556 Sibbald RG, Orsted H, Schultz GS, et al. Preparing the wound bed 2003; focus on infection and inflammation. Ostomy Wound Manage. 2003;49(11):24Ð51 Demling RH, DiSanti L. The role of silver technology in wound healing: effects of silver on wound management. WOUNDS. 2001;13(5):15Ð21.. |
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