Wound healing is a complex and dynamic process that ideally leads to the restoration of anatomical continuity and function.

The process begins at the moment of injury and can take months or years to heal. The wound healing process can be divided into three phases:

(1) inflammatory, (2) proliferation and (3) remodeling.

These three processes are carried out automatically by the personal immune system, which has no problems with its immune system.

This means that any wound that is kept clean and moist will heal spontaneously over time.

Apply Actolind® w Gel to the wound after cleaning the wound with Actolind® w Solution . It is a “leave on” product and forms a protective film layer on the wound bed. This allows scabs and necrotic tissues that are difficult to remove to soften. Leaving the gel on the wound provides continuous coverage. This breaks the connection between the wound and the external environment. The effectiveness of the dressing is increased because the wound surface is well filled. Thanks to this protection later on, the wound surface is protected from infection and the wound is kept stable by preventing the growth of bacteria on the surface.

For small and superficial wounds, use only Actolind® w Solution. For large and deep wounds, wash the wound surface with Actolind® w Solution and then fill the wound surface with a large amount of Actolind® w Gel and then apply a dressing. Actolind® w Gel?

Actolind® w Solution is used to loosen and remove wound coverings; moisten the dressings with the preparation (bandage, dressing, gauze, etc.) and wait 10-15 minutes for the scabs to soften and loosen. Then remove the loosened material and wash the wound with the solution - Actolind® w Solution cleans the wound surface and forms a protective film layer. Then change the dressing and finish the dressing.

For small and superficial wounds, use only Actolind® w Solution. For large and deep wounds, wash the wound surface with Actolind® w Solution and then fill the wound surface with a large amount of Actolind® w Gel and then apply a dressing.

Combination of surfactant (poloxamer) and polyhexanide

• Reduces healing time by keeping the wound clean and moist
• Thanks to the large molecular structure of polyhexanide, the product, which is not absorbed by the skin, forms a protective film on the wound surface. The polyhexanide film layer with antibacterial effect interrupts the connection with the external environment and prevents the growth of bacteria on the wound surface. This keeps the wound surface stable.
• Filling the gap between the skin and plasters, dressings, gauze and other materials and creating a film layer on the wound surface increases the effectiveness of these materials.
• We can shorten the healing process by keeping the wound moist and preventing scabs from forming that stick to the dressing, or by allowing these scabs to break or form again when the dressing is changed.
• It prevents the dressing from sticking to the wound by moistening it before changing the dressing during dressing. This makes the dressing easier to remove and the patient does not suffer from the rupture of scabs stuck to the wound when changing the dressing.

Actolind® w Solution contains the surfactant polyhexanide (PHMB) and purified water. In addition, Actolind® w Gel also has a moisturizing effect.

Actolind® w Solution and Actolind® w Gel are categorized as Class III medical devices according to the European Union Medical Device Directive 2007/47/EC (MDD).

Design tests/clinical trials of Class III devices require a product certificate and an evaluated quality system.

All documentation of class 3 products and systems is carried out by a body authorized by the European Commission.

All relevant regulations must be taken into account when classifying the product.

The products Actolind® w Solution and Actolind® w Gel remain between medical devices and medicinal products when evaluated in this context.

Manual on boundaries and classification in the Community regulatory framework for medical devices – version 1.18 (12-2017) and Meddev 2.1/3 rev 3 The guidance is based on the classification of by-products.

When examining these two documents:

• Wound dressings can be in the form of liquid gels and pastes, etc. (e.g. hydrocolloid and hydrogel)

• It can be seen that products such as irrigation solutions intended for mechanical rinsing (e.g. bladder irrigation solution, eye irrigation solution, etc.) are classified as medical devices.

The main purpose of Actolind® w Solution and Actolind® w Gel is to keep the wound clean and moist. However, dried crusts adhering to the dressing and dead tissue provide a suitable environment for infection to develop.

Polyhexanide is used as a protective antibacterial agent that prevents bacteria from entering the wound from the dressing.

Polyhexanide forms a protective film between the wound and the dressing. This layer interrupts the connection with the external environment and prevents the penetration of bacteria from the external environment into the wound.

Unlike drugs, polyhexanide has no medical or immunological effect on the cell or bacteria. Polyhexanide binds to the acidic phospholipids of the bacterial cell wall through electrostatic interactions.

For all these reasons, it was certified as a Class III product and defined as a medical device.

There are no restrictions on the use of Actolind® w Solution and Actolind® w Gel . They are specially designed for the treatment of wounds that require a long healing time.