Microcyn Technology. Life-Altering Advance in Tissue Care
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- Baldwin Reed
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1 Microcyn Technology Life-Altering Advance in Tissue Care The patented Microcyn Technology mimics the same oxychlorine composition as that manufactured by neutrophils in the body s immune system. Neutrophils are the most abundant type of white blood cells in humans and form an integral part of the immune system. It is safe-as-saline, biocompatible, and shelf-stable technology which has demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores while reducing inflammation and increasing blood flow to treated tissue. Wound Care Microcyn Skin & Wound Care with preservatives and Microcyn Skin & Wound HydroGel provide a formidable wound care combination that has been clinically proven to safely and affordably manage various wound types. Clean and debride wounds including state I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first- and second-degree burns, and grafted and donor sites with Microcyn Skin & Wound Care. This recent advance in tissue care has demonstrated rapid in-solution eradication of MRSA, VRE and other dangerous pathogens with % kill in just 30 seconds, yet is safe to use around eyes, nose and mouth. Following cleaning and debridement, use the Microcyn Skin & Wound HydroGel to dress and protect exudative wounds such as leg ulcers, pressure ulcers, diabetic ulcers and mechanically or surgically debrided wounds. Microcyn HydroGel keeps the wound site moist and provides an ongoing barrier to contamination. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Please see attached device labeling for minimum-cleared indications Tissue Irrigation Microcyn Solution with preservatives is intended for the irrigation and management via debridement of post-surgical and trauma wounds. It has demonstrated rapid in-solution eradication of MRSA, VRE and other dangerous pathogens with % kill in just 30 seconds. It is safe to use around eyes, nose and mouth. With no known drug/ treatment interactions or contraindications, Microcyn Solution is non-foaming, thus providing excellent wound visibility. With self-contained pharmasling hanger, it is easily dispensed and requires no mixing, dilution or rinsing. Safe as saline, Microcyn can be inexpensively disposed of without costly procedures. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner North McDowell Blvd, Petaluma, CA MKT Rev March-12
2 Microcyn Skin & Wound HydroGel Microcyn Skin & Wound HydroGel for medical professionals is intended for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, first- and second-degree burns, and mechanically or surgically debrided wounds. HCPCS# A6248 More Information or Ordering: Because of its proprietary and patented formulation, Microcyn Skin & Wound HydroGel is not affected by the presence of wound fluid, blood and granulation tissue, thus promoting an optimal wound healing environment. Due to its non-toxic nature, Microcyn Skin & Wound HydroGel can be used in all stages of wound healing and is an ideal foundation for wound bed preparation. BENEFITS: No known drug /treatment interactions or contraindications Helps hydrate dry wounds and maintain an optimally moist wound-healing environment Non-staining, non-oily and fully biodegradable Non-irritating, non-sensitizing and non-cytotoxic to granulation tissue Assists in autolytic debridement ph balanced Ideal for uneven and difficult to reach spaces 18-month shelf life Medicare and Medicaid reimbursable INGREDIENTS: Electrolyzed Water (96.524%), Sodium Magnesium Fluorosilicate (3.000%), Sodium Phosphate (0.400%), Sodium Chloride (0.066%), Hypochlorous Acid (0.008%), and Sodium Hypochlorite (0.002%). Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
3 Microcyn Solution with preservatives Microcyn Solution with preservatives is intended for the irrigation and management via debridement of post-surgical wounds. Available in both 500 ml and 990 ml plastic bottles. BENEFITS: No known drug /treatment interactions or contraindications Non-foaming Does not contain antibiotics Does not facilitate resistance Laboratory-proven in-solution inactivation of bacteria and spores Safe to use around the nose, mouth and eyes No mixing, dilution or rinsing necessary 24-month shelf life from date of manufacture No special disposal considerations required PERFORMANCE TESTING Microcyn Solution with preservatives has been evaluated by the USP<51> Antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated in-vitro effectiveness by reducing the microorganisms listed below and passes the USP Antimicrobial Effectiveness Test for a Category 1 product. Microorganism Log Reduction (30 sec.) Time to Kill % Inactivation (30 sec.) Staphylococcus aureus MRSA seconds Enterococcus faecalis VRE seconds Acinetobacter baumannii seconds Pseudomonas aeruginosa seconds INGREDIENTS: Electrolyzed Water: (99.97%), Sodium Chloride (NaCl) (230 mg/l), and preservatives: Sodium Hypochlorite (NaOCl) (40 mg/l), Hypochlorous Acid (HOCl) (30 mg/l) Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
4 MICROCYN TECHNOLOGY MANUFACTURING AND INGREDIENTS: Microcyn Technology contains hypochlorous acid, a compound similar to those naturally produced by the human immune system (neutrophils). The production of HOCl is generated via a proprietary manufacturing process that enables the solution to remain stable. Case Studies Burns/Ulcerations Sixty-three year-old male was severely burned at four years of age, and successfully skin grafted at age of 14. In 1990, the skin grafts ulcerated and became infected with no evidence of healing despite standard care. Microcyn Skin & Wound Care was introduced into patient s treatment regimen in November Once Microcyn was used to clean and debride the wounds, the healing rate accelerated from 2-3mm/week to well over 5mm/week with no further infection or colonization as determined by serial cultures. Week 1 First visit with grey tissue, necrotic tissue and actively bleeding areas. Week 11 First application of Microcyn (notice the improved vascularization of the wound bed). Week 21 Last visit prior to Case Study. Source: Case study by Dr. Cheryl Bongiovanni; January 2006 Stage IV Decubitus Ulcer Sixty-five year-old male developed stage IV decubitus ulcer on left buttock while immobilized. Found to be infected with MRSA, Microcyn under pressure was immediately use to flood the wound and systemic antibiotic administration was avoided. Bulky, dry antimicrobial materials were used to pack and dress the wound. Patient was provided with inflatable ring cushion for sitting and at night was prevented from lying supine. Serial cultures of the wound demonstrated complete sterility by the third day of comprehensive treatment. There was no evidence of necrotic tissue and slough. Ulcer was completely resolved within 30 days. Week 1 Week 4 Week 6 Source: Case study by Dr. Cheryl Bongiovanni; January 2006 Diabetic Foot Ulcer Severely infected diabetic foot with high potential for loss of limb. Week 1: Comprehensive care including Microcyn initiated. Week 2: Granulation tissue begins to appear. Week 5: Improved healthy tissue surrounding wound. Week 18: Wound is completely healed. Source: Case study by Dr. Fermin Martinez; 2007
5 Microcyn Skin & Wound Care with preservatives Microcyn Skin and Wound Care with preservatives is designed for debridement of wounds including stage I-IV pressure ulcers, partial- and full-thickness wounds, diabetic foot ulcers, post surgical wounds, first- and second-degree burns, grafted and donor sites. More Information or Ordering: PERFORMANCE TESTING Microcyn Skin and Wound Care with preservatives has been evaluated by the USP<51> Antimicrobial Effectiveness Test and in solution timekill studies. It has demonstrated in-vitro effectiveness by reducing the microorganisms listed below and passes the USP Antimicrobial Effectiveness Test for a Category 1 product. Name of Organism Log Reduction (30 sec.) Time to Kill Percent Reduction Staphylococcus aureus MRSA seconds % Enterococcus faecalis VRE seconds % Staphylococcus aureus seconds % Escherichia coli seconds % Acinetobacter baumannii seconds % Bacteroides fragilis seconds % Candida albicans seconds % Enterobacter aerogenes seconds % Enterococcus faecium VRE - MDR seconds % Haemophilus influenzae seconds % Klebsiella oxytoca MDR seconds % Klebsiella pneumoniae seconds % Micrococcus luteus seconds % BENEFITS: No known drug /treatment interactions or contraindications Can be used directly on the wound or in combination with gauze and other absorbent wound dressings Safe to use around the nose, mouth and eyes No mixing, dilution or rinsing necessary Can be safely and effectively used prior to treatment with silver dressings, skin substitutes, growth factors, negative-pressure therapy and others wound care treatments Assists in the mechanical removal of proteins and organic loads including biofilms from wound bed 18 to 24 month shelf life depending on bottle type 8 oz. spray, 8.5 oz. dosing and 500 ml dosing bottles. Proteus mirabilis seconds % Pseudomonas aeruginosa seconds % Serratia marcescens seconds % Staphylococcus epidermidis seconds % Staphylococcus haemolyticus seconds % Staphylococcus homins seconds % Staphylococcus saprophyticus seconds % Streptococcus pyogenes seconds % INGREDIENTS: Electrolyzed Water (99.97%), Sodium Chloride (NaCl) 0.023% and preservatives: Sodium Hypochlorite (NaOCl) 0.004%, and Hypochlorous Acid (HOCl) 0.003%. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
6 Clinical Practice Instructions for Use (See label for cleared instructions for use) Microcyn Skin & Wound Care with preservatives and Microcyn Skin & Wound HydroGel. 1. Assess Macrovascular Status: If compromised, refer for macrovascular intervention. If painful, soak extant dressing with 2% lidocaine for minutes. If no pain, or when pain subsides, wash wound with Microcyn WC, volume sufficient for wound size and amount of exudate status Debride Wound: Debride as necessary with Microcyn wash, Microcyn under pressure, with or without mechanical removal of devitalized material. If required, refer for sharp debribement/excision. 3. Obtain Culture Specimen: 2 Wash wound with Microcyn WC 3 a. Sterile/No Growth Wound HydroGel. Bandage appropriately and change dressing daily until healing begins. Change dressing and bandage appropriately two to three times per week until healing begins. b. Widely Sensitive Organisms (Susceptible to many antibiotics) Wound HydroGel. Bandage appropriately and change dressing at least twice per week until healed. Mechanically debride 4 Use Microcyn WC with pressure c. Multi-drug Resistant Pathogens Wound HydroGel. Bandage appropriately with dressing change AT LEAST DAILY until healing begins. Decrease dressing change frequency as appropriate until healed. Wound HydroGel. 5 Bandage appropriately and change dressing as often as necessary until healing begins. Clinical Practice Instructions for Use (See label for cleared instructions for use) Microcyn Solution with preservatives Negative-Pressure Wound Therapy Systems: Microcyn Solution can be provided to a wound site via the ingress and egress surgical tubing that is common with these various negative-pressure systems. Safe as saline, the Microcyn Solution is compatible with all major NPWT systems. Wound Drip: Microcyn Solution can be directly dripped from IV via a vented spike into a wound site. Note: Wound healing rates and characteristics will vary significantly with patient age, nutritional status, metabolic status, immunologic status and compliance. In the presence of vascular compromise, care must be taken to avoid circumferential bandage compression pressures in excess of arterial perfusion pressures.
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