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AQUACEL Ag Foam Non-adhesive format Description Multi-layered, non-adhesive, antiseptic, cut-to-size dressing made of hydrocellular polyurethane foam with a honeycomb structure, accompanied by a hydrofibre layer in contact with the wound bed with 1.2% by weight of silver ions, a polyurethane binding layer and an external polyurethane film. The mixed-cell polyurethane layer is highly hydrophilic, absorbent, exudate-retaining, and breathable. The Hydrofiber Technology layer, in direct contact with the wound bed, allows Aquacel Ag Foam to actively interact with the wound, vertically absorbing exudate, retaining it, and instantly forming a soft gel that maintains an optimal moist environment and promotes healing, reducing the risk of maceration of the periwound skin, even under compression. The gels conformability to the wound bed prevents the presence of empty spaces that can lead to bacterial growth. The rounded corners prevent the dressing from rolling up. The presence of ionic silver ensures the dressing has a broad-spectrum, rapid, and long-lasting antimicrobial effect, without being cytotoxic or irritating. The polyurethane binding layer facilitates fluid transfer between the hydrofiber layer and the foam layer, maintains the dressings structure even when cut, and ensures single-piece removal. The breathable external film promotes the permeability of vapors and gases but at the same time creates an impermeable barrier to fluids, viruses and bacteria, protecting the wound from external contamination. They are indicated for: lesions with infection or at increased risk of infection; lower limb ulcers; venous stasis ulcers; lower limb ulcers of mixed etiology; arterial ulcers; pressure ulcers; diabetic foot ulcers; surgical wounds; partial-thickness burns; traumatic lesions. They are intended to be used by healthcare professionals, caregivers, and patients under the guidance of a healthcare professional. How to use Before applying the dressing, clean the wound area with an appropriate wound cleanser and dry the surrounding skin. Select a dressing with a size such that the central absorbent pad (area within the edge of the adhesive window) is 1 cm larger than the wound area. Remove the dressing from the sterile package, avoiding touching the surface in contact with the wound. The dressing can be trimmed to size for convenience. Place the dressing over the wound and align the center of the dressing with the center of the wound. Place the pad directly over the wound. Avoid stretching the dressing during application. Ensure joints are sufficiently loose to allow the patients mobility. To secure the dressing in place, if it does not have an adhesive edge or if it has been cut, use a suitable containment bandage or tape. After placing the dressing on the wound, discard any unused portions of the product. The dressing should be changed when clinically indicated (e.g., if there is leakage, bleeding, or increased pain). The maximum recommended application time is 7 days. The wound should be cleaned at appropriate intervals. To remove the dressing, gently press on the skin and carefully lift one corner of the dressing. Continue until all edges are free. Carefully lift the dressing and dispose of it according to local clinical protocols. The need for the dressing should be reassessed after 14 days and, if appropriate, an alternative wound management system should be considered. Components Sterile dressing composed of an external waterproof polyurethane film, a layer of hydrophilic polyurethane (2.5 mm thick, density of approximately 300 g/m2 and cell size of 200-300 microns), an absorbent layer of pure CMCNa gelling fibres with the addition of 1.2% by weight of silver ions. Latex free. Warnings Product sterility is guaranteed if the packaging is intact and has not been opened before use. Do not use the device if the packaging is damaged or opened before use. The device must be disposed of in accordance with local regulations. Dressings are intended for single use only and should not be reused. Reuse may increase the risk of infection and cross-contamination, and may delay healing. Although they are water-resistant, they should not be immersed in bathing or swimming. They should not be used with other wound care products without first consulting a healthcare professional. They are not compatible with oil-based products. They should not be used on sensitive individuals or those who have had an allergic reaction to the dressing or its components. They are not compatible with oxidizing agents such as hydrogen peroxide or hypochlorite solutions. Occasionally, newly formed blood vessels may produce a bloody wound exudate. Physicians/healthcare professionals should be aware that there is very limited data on the prolonged and repeated use of silver-containing products, particularly in children and infants. Silver-containing products have been observed to carry a risk of skin discoloration with prolonged use, but this is often transient and resolves once the silver-containing dressing is discontinued. A healthcare professional should be consulted if any of the following conditions are observed during dressing changes: irritation (redness, inflammation), maceration (whitening of the skin), hypergranulation (formation of excess tissue), signs of infection (increased pain, bleeding, warmth/redness of the surrounding tissue, wound exudate), or a change in the color and/or odor of the wound. After use, the product may pose a potential biological hazard. Handle and dispose of the product in accordance with accepted medical practices and applicable national and local laws and regulations. If a serious incident occurs during or as a result of the use of this device, the incident must be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient reside. Conservation Store in a dry place at room temperature (10°C - 25°C) and protect from light. Shelf life when packaging is intact: 3 years. Format Pack of 10 pieces of 10 x 10 cm. Code 420642
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