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The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows: Over-The-Counter (OTC) use indications: Local management of superficial wounds, minor burns, abrasions and lacerations (tears). Prescription use indications (Rx-only): - · Partial and full thickness wounds, - · Pressure ulcers (stage I-IV), - · Diabetic ulcers, - · Venous stasis ulcers, - · Arterial ulcers, - · 1st and 2nd degree burns. - · Surgical wounds, - · Vascular access or peripheral IV sites, - · Orthopedic external pin sites, and - · Acute wounds such as lacerations, abrasions, and skin tears.

The MedCu Antibacterial Wound Dressings with Copper-Oxide are sterile, soft, single use, barrier wound dressings composed of an internal absorbent layer and one or two external nonwoven layers (only the adhesive contour model serves as physical barrier). The external layer(s) are made of Polypropylene nonwoven fabric and the internal layer is made of needle punch layer made of Polyester and Cellulose fibers. The wound dressings achieve at least 500% fluid absorbency. Both the internal and external layers are impregnated with copper-oxide particles. The one or two external layers cover the internal layer from one or both sides, accordingly. The wound dressing size is of 10 cm x 10 cm or 5 cm x 5 cm (other variations may be included as well), and may be provided with or without an adhesive contour (adhesive border), which provides physical bacterial barrier. The wound dressings without an adhesive contour can be cut per wound shape. The Copper-Oxide ions are released within the wound dressing from the polymeric matrix of each layer in the presence of moisture. The MedCu ABWDs, reduced the tested bacteria by more than 4 log within the wound dressing based on in-vitro testing. MedCu ABWDs absorb wound fluid, contain copper-oxide to inhibit bacterial growth within the dressing and serves as a *barrier against bacterial penetration. *Note: Barrier against bacterial penetration is achieved only by the adhesive contour model. The wound dressing is provided sterile and kept sterile in a sterilization pouch for its entire shelf life. Body contact materials were evaluated for biocompatibility with accordance to FDA's Guidance document for Use of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing with a Risk Management Process, dated June 16, 2016 and the ISO 10993-1:2009 standard.