Description
Biatain Silicone Ag
Absorbent polyurethane foam with silver and silicone adhesive layer.Class III medical device.
Description
Antibacterial, absorbent, multi-layered dressing, composed of an absorbent layer in polyurethane foam, two layers of polyurethane film, one external and one internal and a final layer, in contact with the lesion and the skin, in delicate perforated adhesive silicone. The antibacterial, absorbent layer, covered in perforated silicone, is made of Biatain polyurethane foam, multi-layered, hydrophilic, with a vertical alveolar structure, which releases silver ions onto the lesion bed in a continuous and controlled manner, to guarantee antibacterial action up to the seventh day. The release of silver ions, (intelligent release of the Alphasan complex) is unique and patented. The silver-based compound is homogeneously distributed within the polyurethane foam. Thanks to the special 3D vertical alveolar technology it absorbs and prevents the release of exudate even under compression, thus creating the ideal moist environment for the healing process of the lesion, and avoiding maceration of the perilesional skin. The polyurethane foam is positioned without steps at the same level as the wound, avoiding any pressure marks on the periwound skin. In contact with the exudate, the foam conforms optimally to the wound bed, reducing dead spaces where bacteria can nest. The external polyurethane film layer, in direct contact with the foam layer, creates a barrier to exogenous bacteria and external pollutants and ensures high breathability. It also ensures optimal fluid management thanks to its high permeability. The internal polyurethane film layer that adheres to the polyurethane foam on one side and to the silicone on the other, creates an intermediate layer that prevents delamination of the foam in the presence of a humid environment. The external adhesive silicone layer, in contact with the wound and the skin, is perforated (with patented Coloplast technology) along the entire surface, both of the foam and the edge. The silicone adhesive layer is gentle and does not cause trauma to the wound during dressing changes and application. The perforation in correspondence with the polyurethane foam allows the passage of exudate towards the absorbent layer of the dressing and also ensures a secure adhesion of the dressing. The perforation on the edges ensures adequate transpiration and evaporation of moisture from the skin.
Directions
Acute and chronic skin lesions with high bacterial load, which delays the healing process, medium to high exuding. The dressing can be used prophylactically or on infected ulcers under medical supervision. Average residence time (medium to high exuding lesions and ulcers): 3-4 days. Maximum residence time in site: 7 days.
Contraindications and incompatibilities
Do not use Biatain Silicone Ag in subjects with known hypersensitivity to silver and its derivatives. In case of allergic reactions, please contact Coloplast for information on the components. Biatain dressings and secondary dressings must be removed before radioactive treatment (X-rays, ultrasound treatment, diathermy and microwaves). Do not use Biatain dressings with oxidizing solutions such as hypochlorite and hydrogen peroxide.
Composition
External and internal polyurethane film, polyurethane foam, perforated silicone adhesive layer. The foam contains a silver-based compound, AlphaSan complex, an ionic complex with “smart release” of silver that releases silver when it comes into contact with sodium ions present in the wound exudate.
Antibacterial activity
Biatain Silicone Ag is effective against microorganisms commonly present in lesions for up to 7 days. Skin flora bacteria, such as: Acinetobacter, Coag. neg. S. epidermidis, E. Cloacae, E. Coli, E. Faecalis, E. Faecium, Hemolytic streptococci, gr. A, P. Aeruginosa, P. Mirabilis, P. Vulgaris and S. Aureus. Tissue bacteria such as: Anaerobic Streptococcus, B. Fragilis, C. Perfringens. Resistant bacteria including MRSA and VRE.
Chemical-physical characteristics
| Product | Silver content mg/cm² | Absorption g/m2, 1 h | Absorption g/m2, 24 h | Absorption under compression g/m2, 24 h | Permeability (MVTR) g/m2, 24 h | Fluid Handling (FHC) g/m2, 24 h |
| Polyurethane Foam Dressing with Silver and Silicone Adhesive Layer | 0.95 | 4.780 | 5.600 | 2,500 | 9.200 | 14,800 |
Sterilization
Biatain Silicone Ag is sterilized with ethylene oxide. Each package has the lot number and expiration date.
Validity
2 years from date of manufacture, unless otherwise indicated on the packaging.
Codes
| Product | Commercial Code | Size (cm) | CND Code | ISO code | GMDN Code |
| Polyurethane foam dressing with silver and silicone adhesive layer | 39636 | 7.5x7.5 | M04040802 | 09.21.12.003 | 48124 |
| Polyurethane foam dressing with silver and silicone adhesive layer | 39637 | 10x10 | M04040802 | 09.21.12.003 | 48124 |
| Polyurethane foam dressing with silver and silicone adhesive layer | 39638 | 12.5x12.5 | M04040802 | 09.21.12.003 | 48124 |
| Polyurethane foam dressing with silver and silicone adhesive layer | 39639 | 15X15 | M04040802 | 09.21.12.003 | 48124 |
| Polyurethane foam dressing with silver and silicone adhesive layer | 39640 | 17.5x17.5 | M04040802 | 09.21.12.006 | 48124 |
Packaging
| Unit of use | 1 dressing in single pack. |
| Order unit 39636 39637 39638 39639 39640 |
5 units of use 135 x 147 mm 5 units of use 165 x 177 mm 5 units of use 166 x 177 mm 5 units of use 220 x 227 mm 5 units of use 226 x 227 mm |
| Packaging 39636 39637 39638 39639 39640 |
32 Order units 48 Order Units 48 Order Units 24 Order Units 24 Order Units |
Product storage
Products must be stored at room temperature (25°C).
Disposal
The product does not contain ecotoxic components and therefore does not require special disposal protocols. Do not dispose of in the environment as it is not biodegradable.
Code 39636/39637/39638/39639/39640
