Product Description

Medisorb Absorb Silicone is an advanced superabsorbent dressing indicated for the management of moderately to highly exuding wounds, supporting the maintenance of an optimal, moist wound-healing environment. The device features a four-layer construction, centered around an absorbent core with superabsorbent polymer (SAP). This core is located between an outer fluid-repellent, breathable backing, a fluid-permeable intermediate layer, and a soft silicone contact layer. The dressing is made of polypropylene, polyethylene, cellulose, polyacrylate, and soft silicone.

Mode of Action 

The dressing rapidly absorbs exudate, irreversibly sequestering its matrix metalloproteinases (MMPs) – enzymes responsible for the degradation of newly forming tissues – within its structure. Due to this high binding capacity, the device effectively isolates harmful substances from the wound bed, ensuring an optimal moist environment conducive to tissue regeneration. Within the absorbent layer, SAP polymers transform fluid into a cohesive gel, preventing maceration of the wound edges. By depriving MMPs of these essential co-factors and physically locking them within the gel matrix, the device precisely modulates the wound's biochemical environment and breaks the cycle of chronic inflammation. Additionally, the silicone contact layer provides gentle and secure adhesion to the surrounding skin while remaining completely atraumatic to the wound bed.

Properties

• High absorption capacity: The absorbent core rapidly absorbs and permanently isolates large volumes of exudate, preventing backflow (strike-through) to the wound bed, which allows for less frequent dressing changes.
• Minimises pain removal: The silicone contact layer minimises patient pain and minimises the risk of trauma to newly formed tissue (granulation and epithelial tissue) during dressing removal. Thanks to advanced silicone coating technology, the dressing allows for repositioning during application and lifting of the border for wound bed inspection – if deemed necessary by a qualified healthcare professional during the course of treatment – without losing its adhesive properties and in strict compliance with the single-use principle.
• Reduce the risk of maceration: The secure retention of exudate and excess proteolytic enzymes (matrix metalloproteinases – MMPs) within the absorbent core significantly minimizes the destructive impact of fluid on tissues, reducing the risk of maceration to the wound edges and delicate surrounding skin.
• Breathability: The outer fluid-repellent layer enables gas exchange (moisture transpiration) while protecting against the penetration of external fluids.
• Safety in compression therapy: The dressing exhibits high resistance to external pressure. It effectively retains exudate within the gel structure even under compression bandages, without losing its absorbent properties.

Indications

The dressing is indicated for the management of moderately to highly exuding wounds, including:

• Venous leg ulcers.
• Pressure ulcers.
• Diabetic foot ulcers.
• Surgical wounds.

Instructions for use

The device must be used strictly in accordance with the indications provided in the instructions for use and under the supervision of a physician or nurse to ensure a correct and hygienic application. Before use, please read the full instructions for use carefully.

Contraindications and Safety

• Contraindications: Do not use on dry/low exuding wounds, third-degree burns, eyes, mucous membranes, or wound cavities. Contraindicated if sensitive to components.
• Warnings and Precautions: Do not use if sensitive to components. If an allergic reaction occurs, discontinue use and consult a physician. Sterile, single-use product. Do not cut the dressing. Do not use if package is damaged. Avoid standing on the dressing. Consider dressing expansion (swelling) during application. Exercise caution with wounds prone to bleeding. Use in sensitive groups (infants, children, pregnant or breastfeeding women) only as recommended by a physician.

Manufacturer: Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd. Dongjiang Hi-tech Industry Park 516005, Huizhou, PEOPLE’S REPUBLIC OF CHINA

EU Authorized Representative: Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany

Product Certification: CE 0123 (Notified Body: TÜV SÜD Product Service GmbH)

Advertising Entity / Distributor: Toruńskie Zakłady Materiałów Opatrunkowych S.A.