Questions / Answers
Wound healing is a complex and dynamic process that ideally leads to restoration of anatomic continuity and function. The process begins at the moment of the injury and the wound healing can take month or years. The wound healing process can be divided into three stages:
(1) Inflammatory, (2) Proliferation and (3) Remodeling.
These three processes are carried out automatically by the personal immune system who does not have any problems with its immune system.
That means every wound that is kept clean and moist heals spontaneously over time.
Acute injuries are usually traumatic or surgical. Generally, these injuries occur suddenly, healing process is fast and normal wound healing ideally processes without any major complication. Examples of acute wounds are ruptures, animal stings or knife wounds. A chronic wound can be defined as a wound that is stuck in one or more of the normal wound healing processes (usually the inflammatory phase). Acute wounds heal quickly and properly when they are compared to chronic wounds which have characteristic features. Most of the chronic wounds can be divided into three categories: venous ulcers, diabetic ulcers and pressure ulcers.
A qualified wound care is achieved by preventing wound infection, trauma or contract with highly malignant agents and by avoiding from the conditions which may cause another surgical intervention. For this reason, it is necessary to keep the wound clean, moist and to disconnect from the external environment against the infection factors.
Actolind® w Solution and Actolind® w Gel is categorized as Class III Medical Devices according to European Union Medical Device Directive 2007/47/EC (MDD). Class III device design/clinical trial examinations require the product certificate and an evaluated quality system. All documentations of third class products and systems are performed by a body authorized by European Commission.
When a product is classified, all relevant regulations must be considered. Actolind® w Solution and Actolind® w Gel products remain between the medical device and the drug products when it is evaluated in this context. Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices -Version 1.18 (12-2017) and Meddev 2.1/3 rev 3 Guidance are based on for the classification of byproducts. When these two documents are examined:
• Wound dressings may be in the form of liquid gels and pastes, etc. (e.g. hydrocolloid and hydrogel)
• It is seen that the products such as irrigation solutions intended for mechanical rinsing (e.g. bladder irrigation solution, ocular 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, the dried crusts adhered to the bandage and dead tissues provide a suitable environment for infection development. Polyhexanide is used as a protective antibacterial substance to prevent that bacteria penetrates from dressing to the wound. The polyhexanide forms a protective film layer between the wound and the dressing. This layer cuts off the connection with the external environment and prevents the penetration of bacteria from outer environment to the wound. Unlike drugs, polyhexanide does not have any medical or immunological effect on the cell or bacteria. The polyhexanide binds to acidic phospholipids of bacteria cell wall through electrostatic interaction. Due to all these reasons, it has been certified as a Class III product and defined as a medical product
Actolind® w Solution contains a surfactant, Polyhexanide (PHMB) and pure water. In addition to that, Actolind® w Gel has also moisturizing effect.
Combination of surfactant (Poloxamer) and Polyhexanide
– Shortens the healing period by keeping the wound clean and moist
– Due to the large molecular structure of polyhexanide, the product, which is not absorbed by the skin, forms a protective film layer on the wound surface. Polyhexanide film layer with antibacterial effect cuts off the connection with outer environment and prevents the bacterial growth on wound surface. Thus, it keeps the wound surface stable.
– Filling the gap between the skin and the sticking plaster, compress, gauze and other materials and creating a film layer on the wound surface increase the efficiency of these materials.
– Healing process is shorten by keeping the wound always moist and not letting the creation of scabs, which is adhered to the dressing, or rupturing these scabs during the dressing change, or letting its reoccurrence.
– It prevents the adhesion of dressing to the wound by wetting it before chancing the bandage during the dressing. Therefore, the dressing is removed more easily and the patient does not have any pain during the dressing change due to the rupture of scabs adhered to the wound.
Yes. Poloxamer, a surfactant, and the moisturizing agent. Glycerin softens the scab and necrotic tissue on the wound surface. Thus, it helps to remove the necrotic tissue from the wound surface by washing, softening and loosening and then removing the necrotic tissue.
Actolind® w Solution: To loosen and remove the wound covers; wet the bandages with the product (compress, bandage, gauze, etc.) and wait for 10-15 minutes to let the scabs soften and loosen. Then, remove the loosened material and wash the wound with Actolind® w Solution. Actolind® w Solution will clean the wound surface and create a protective film layer. Then, replace the bandage and end the dressing procedure.
Actolind® w Gel: Apply it to the wound after the wound is cleaned with Actolind® w Solution. It is a «leave on» product and will create a protective film layer on wound bed. This lets the scabs and necrotic tissue, which are difficult to remove, to be softened. Leaving the gel on the wound provides a continuous cover. Thus, the connection between the wound and outer environment is cut off. Efficiency of bandage is increased because the wound surface is filled well. Due to this protective later, the wound surface is protected from the infection and the wound is kept stable by preventing bacteria growth on the surface.
In case of small and surface wounds, only use Actolind® w Solution. In case of big and deep wounds, wash the wound surface with Actolind® w Solution and then fill the wound surface with plenty of Actolind® w Gel, and then apply the bandage.
There is not any limit for the use of Actolind® w Solution and Actolind® w Gel. They are especially designed for the treatment of the wounds which require long healing period.