FAQ  – ActiMaris®

 

General product questions

ActiMaris® products are well-tolerated based on natural, pure sea water and active oxygen. They clean the wound effectively, reduce inflammation, have a decongestant effect and ensure the active, rapid and long-lasting reduction of odours. In addition, ActiMaris® has a decontaminating and antibacterial effect, and efficiently dissolves biofilms. As with seawater, the components of the products are present in their natural complex compounds and in physiologically correct concentrations. This means they have a positive influence on the cell environment and wound metabolism. The products are also suitable for sensitive, irritated and inflamed skin and mucous membranes. ActiMaris® is available as Wound Irrigation Solution sensitive, Wound Irrigation Solution forte and as a Wound Gel.

ActiMaris® Wound Irrigation Solution sensitive

Clear, colourless, alkaline and hypertonic sea salt solution with characteristic smell. Contains sea salt, water. NaCl 1.2% (Sal Maris) and NaOCl 0.04%.

ActiMaris® Wound Irrigation Solution forte

Clear, colourless, alkaline and hypertonic sea salt solution with characteristic smell. Contains sea salt, water. NaCl 3% (Sal Maris) and NaOCl 0.2%.

ActiMaris® Wound Gel

Clear, colourless, basic and hypertonic gel with characteristic odour. Sea salt, water, lithium magnesium sodium silicate. NaCl 3% (Sal Maris) and NaOCl 0.2%.

ActiMaris® Wound Irrigation Solution sensitive

Used for cleaning, rinsing, moistening and decontaminating wounds and can be used to detach wound dressings and adhesive dressings as well as for intraoperative cleaning and rinsing of wounds. The Wound Irrigation Solution sensitive is suitable for short and long-term use. It is pain-free and well-tolerated, even by allergy sufferers and patients with sensitive skin.

ActiMaris® Wound Irrigation Solution forte

Is particularly suitable for the initial cleaning of strongly fibrinous or purulent, infected or strongly foul-smelling wounds. The higher NaCl and NaOCl content means that ActiMaris® Wound Irrigation Solution forte provides intensive cleaning of the aforementioned wound conditions. After the state of the wound has improved, it is recommended to use ActiMaris® Wound Irrigation Solution sensitive for subsequent wound cleansing.

ActiMaris® Wound Gel

Is suitable for cleaning heavily fibrinous or purulent, infected or foul-smelling wounds and for filling deep defect wounds. ActiMaris® Wound Gel can be used to re-hydrate dry wounds and treat both irritation and inflammation of the skin and mucous membranes. ActiMaris® Wound Gel is particularly well-tolerated and suitable for both short and long-term use.

ActiMaris® products clean the wound effectively, minimise inflammation, have a decongestant effect and reduce odours quickly and long-lastingly. In addition, ActiMaris® has a decontaminating and antibacterial effect and effectively dissolves biofilms. Furthermore, the singlet oxygen (active oxygen) as a signal molecule supports granulation and the process of epithelisation. The benefits can be attributed to the optimal interaction of ionised seawater, active oxygen and a high pH value. The following properties can be attributed to the individual components:

Ionized sea water

Due to the ionised sea water, a deep penetration of the products can be achieved, as the H2O molecules in ionised water are smaller and can therefore penetrate deeper into the tissue. Electrostatic voltages stimulate cell migration.

Reactive Oxygen Species (ROS)

Reactive oxygen species (ROS), which also include active oxygen (singlet oxygen), play an important role in a variety of biological processes and are very important as the regulators of immune reactions. Active oxygen is produced by granulocytes and macrophages and creates an environment that is hostile to germs, which means that it has a naturally preserving and germ reducing effect. The active oxygen also inhibits the release of histamine, which is also responsible for the development of wound swelling. It also eliminates typical wound pathogens without damaging the tissue and neutralises odours. The singlet oxygen in ActiMaris® marks an innovation, as for the first time it has been possible to stabilise the energy-rich form of oxygen for a longer period of time and to use it therapeutically for long-term application by stably embedding it in a sodium oxychlorite complex.

High (alkaline) pH value of 8.5 – 10

In order to avoid causing cell damage, ROS substances, including active oxygen, must be kept in balance with antioxidants. The redox system ensures balance in the body. In a redox reaction, an electron exchange takes place in which a reaction partner transfers electrons to another substance. Due to the high alkaline pH value, ActiMaris® contains a natural redox system, since alkaline substances counteract oxidation and render harmless the increased concentration of free radicals through chemical neutralisation. In addition, enzymes, signal molecules, neurotransmitters and growth factors, which are important for the individual wound healing phases, can optimally exert their effect in the alkaline environment.

1,2 – 3,0% sea salt

Since the sea salt concentration lies above the physiological value of 0.9%, a , an osmotic and therefore decongestant effect occurs in the wound tissue. This reduces wound pain.

Singlet oxygen, also known as active/energetic/nascent oxygen, belongs chemically to the group of reactive oxygen species. Through a special electrolysis process ActiMaris® is stably incorporated into the sodium chloride complex from sea water and manifests itself as NaOCl = sodium oxychlorite. Macrophages and granulocytes use active oxygen to harm bacteria. Active oxygen is only toxic for bacteria, but not for cells in the body, which are also capable of flushing out excess oxygen.

Singulet oxygen wants to combine with other substances to compensate for the missing electron. The exudate only slowly reduces the high alkaline value of ActiMaris® which is why the release of active oxygen from the NaOCL compound is not explosive, but occurs slowly.

Using a special electrolysis process, the active oxygen in ActiMaris® can be stably embedded in a sodium chloride complex. This compound, which serves as a carrier substance, appears as sodium oxychlorite (NaOCl). As soon as ActiMaris® comes into contact with the wound, skin or mucous membrane, the active oxygen splits off – NaCl is produced as a by-product. Sodium oxychlorite has a specific smell reminiscent of chlorine or swimming pools. However, because of the high pH value in ActiMaris® (8.5 – 10) in terms of chemistry no elements of chlorine be present, because this only forms from a pH of 2.0 and downwards. The hypochlorous acid (HOCl) is only present in traces at a pH value of 8.0 and from a pH value of 8.5 only appears as OCl (oxychlorite) – as a ROS substance.

When ActiMaris® is applied to an unpleasant smelling wound, the sodium chloride and active oxygen react with the odour molecules and neutralise them.

As in sea water, trace elements and minerals in the products are present in their natural complex compounds and in physiologically correct concentrations (like in serum) and therefore contribute to anti-inflammatory processes. They also have a positive effect on the cell environment and the metabolism of wounds.

The anti-inflammatory properties produce a decongestant effect. This is also achieved by reducing excessive histamine production, due to the active oxygen. The slightly increased NaCl concentration of 1.2% or 3% (osmotic soaking effect) also amplifies this effect.

Technical questions

ActiMaris® products should be stored at room temperature between +5° and +25 °C and shielded from direct sunlight. Sodium oxichlorite binds the active oxygen and acts as a natural preservative. For this reason ActiMaris® products have a shelf life of 2.5 years and can be used for up to 3 months after opening. The long shelf life was proven by stability and conservation tests.

If ActiMaris® is exposed to higher temperatures over a longer period of time, the active oxygen is released before the Wound Irrigation Solution or Wound Gel comes into contact with the wound exudate. This may weaken the positive effects of ActiMaris®.

It is recommended to use the ActiMaris® Wound Irrigation Solution / Wound Gel at room temperature. For wounds with an increased propensity for pain, the ActiMaris® Wound Irrigation Solution / Wound Gel can be warmed to body temperature immediately before administration. It is not recommended to warm it up for a prolonged period before use to avoid consuming the active oxygen before the use of ActiMaris®.

It cannot be precluded that coloured textiles may become discoloured following contact with ActiMaris®. This is due to the active oxygen, which can have a discolouring effect. If ActiMaris® comes into contact with clothing, the ActiMaris® Wound Irrigation Solution / Wound Gel should be rinsed out with clean water.

No, ActiMaris® is not sterile, but it is produced under perfect hygienic conditions. As ActiMaris® products hace an antibacterial action and NaOCl (sodium oxychlorite) and sea salt act as natural preservatives, contamination does not take place until they are used up. This has also been confirmed by the results of the conservation test.

Medical questions

ActiMaris® exerts a hyperosmotic effect on the cells through the electrolytes (especially NaCl), thus reducing the tension in the tissue and consequently the pressure and irritation on the mechanoreceptors in the skin. Strontium in sea water (strontium chloride) reduces the hypersensitivity of the nociceptors (as in toothpaste Sensodyne), which decreases or blocks the sensation of burning and pain.

ActiMaris® products can be combined with all inert, non-active wound dressings (e.g. compresses, gauzes, foams, gels, hydrofibres, alginates, hydrocolloids etc.). There are no laboratory tests available for the use of ActMaris in combination with dressings containing silver. However, a multi-centre survey of medical staff showed empirically that no negative interactions were to be expected from a combination of ActiMaris® with dressings containing silver. The ActiMaris® Wound Irrigation Solution can be used with other ActiMaris® products (Wound Gel and Wound Irrigation Solution forte).

Yes, ActiMaris® Wound Irrigation Solutions “sensitive” and “forte” have already been used with good results in combination with vacuum therapy.

In order to achieve optimum effects during wound cleansing, antiseptic substances and/or Wound Irrigation Solutions should be in the correct concentration and the recommended exposure times should be observed. For ActiMaris® Wound Irrigation Solution sensitive, the following applies: if there is a stable wound environment and a clean wound bed, a 5-10-minute exposure time is recommended, which is increased to 15 minutes if fibrin coatings or macerations are present. In the case of heavily fibrin-covered, germ-covered and foul-smelling wounds, the exposure time should be 20 minutes. If the recommended exposure times are not adhered to, the minimisation of odours and inflammation is attained to a lesser extent. If the recommended longer exposure times for fibrin/germ colonised and bad smelling wounds cannot be adhered to due to the challenges of everyday practice, the wound can be treated with ActiMaris® Wound Gel. To this end, the wound should first be cleaned with ActiMaris® Wound Irrigation Solution before applying the ActiMaris® Wound Gel. The Wound Gel should then be generously applied onto or into the wound and covered with a suitable dressing.

There are various mechanisms of action for autolytically dissolving wound dressings, biofilms and necrosis. Alongside the hypertonic salt concentration, biological debridement can be achieved by ActiMaris® due to the alkaline pH value, as this promotes the effect of the alkaline proteases. In addition, due to the smaller water cluster, there is improved diffusion into the damaged tissue.

Also in the stress test, the use of ActiMaris® with aerobic bacteria was proven in vitro as well as in vivo, and with optimal results. The energy in the active oxygen (158 kJ/mol) is so strong that the bacterial membranes of both aerobic and anaerobic bacteria literally burst within milliseconds up to seconds. At a pH of 9.5 – 10.0 (as with ActiMaris® Wound Irrigation Solution forte and ActiMaris® Wound Gel), even bacterial spores are destroyed. The wound healing process is thereby accelerated; this has also been proven by past clinical experience.

No, quite the opposite. The active oxygen in ActiMaris® reacts with the molecules in the wound that are responsible for bad smells and thereby contributes to a rapid and long-lasting odour reduction, which the patient perceives as being very pleasant.

No, not if the products are used as directed. If the ActiMaris® Wound Gel is applied beyond the edges of the wound, the possibility of a maceration process can even be prevented.

The slightly hypertonic salt concentration in ActiMaris® creates an osmotic effect that is responsible for the decongestant effect of ActiMaris®. This is a temporary “stimulus reaction ” whereby ActiMaris® binds the excess moisture to the skin without drying out the wound.

  • Not to be used on patients with a sensitivity to any of the ingredients.
  • Indicated for external use on skin and mucous membranes only.
  • Not to be used for infusion or injection and not to be ingested.
  • Only perfect, undamaged containers should be used.
  • Not to be used together with external agents containing active ingredients.

In order to avoid any potential interactions, the Wound Irrigation Solution should not be used at the same time as or mixed with external agents containing active ingredients (e.g. solutions containing silver, biguanide, taurolidine or iodine, or wound dressings containing iodine) (see also the question: “Which wound dressings can ActiMaris® be combined with without hesitation?”) If the Wound Irrigation Solution is applied at the classic moist dry phase and the appropriate drying time is observed, interactions with wound care products used subsequently should not be a concern.

No side effects have been observed with the use of ActiMaris® products. ActiMaris® Products are also suitable for sensitive/irritated skin and mucous membranes. They are painless and are generally well tolerated, even by allergy sufferers. There is no risk of inhibiting granulation and epithelialisation; the ActiMaris® Wound Irrigation Solutions and ActiMaris® Wound Gel are dermatologically harmless. However, ActiMaris® should not be used if an allergy to one of the ingredients is known or suspected.

ActiMaris® is produced without artificial preservatives, so a very high compatibility of the products can be guaranteed. The NaOCl (sodium oxychlorite) and sea salt contained in ActiMaris® act as natural preservatives.

There is no evidence of the ingredients having mutagenic or embryotoxic effects. Due to lack of trials and long-term experience in pregnant women and nursing mothers, ActiMaris® products should only be used in these cases after carrying out a careful medical risk-benefit analysis.

Due to insufficient long-term experience, ActiMaris® should only be used in these cases after a careful medical risk-benefit analysis.

The following publications about ActiMaris® are available on request from ActiMaris AG:

  • “Multicentric case studies of secondary healing/chronic wounds with sea salt-based solutions and gels with nascent oxygen 1O” (Gerhard Kammerlander)
  • „A clinical evaluation of the efficacy and safety of singlet oxygen in cleansing and disinfecting stagnating wounds.” (Gerhard Kammerlander)( English version in the Journal of Wound Care)
  • „ActiMaris® – Clinical ORL study in inflammatory skin and mucous membrane processes”. (Dr. Marincic), 2010

The cytotoxicity laboratory tests performed with ActiMaris® show that using ActiMaris® ensures safe use. Actimaris® is non-toxic (see laboratory tests and trials) and hence well suited to long-term use. The products also do not contain any exogenous ingredients, so they are very well-tolerated.

No. In cases of clinical infection, systemic antibiotic treatment or another appropriate infection treatment should also be envisaged.

Questions about handling

ActiMaris® Wound Irrigation Solution sensitive

For wound cleansing, inert dressings or wound dressings soaked in ActiMaris® Wound Irrigation Solution sensitive can be used. The application can take place in the form of the classic moist-dry phase (according to G. Kammerlander). The length of the moist phase needs to be adjusted according to the thickness and strength of the fibrin coatings, microbial colonisation, wound edge maceration or irritation:

  • Stable wound environment, clean wound bed, no microbial contamination: 5-10 minutes
  • Fibrin coating, without microbial contamination, with wound edge maceration/irritation: 15 minutes
  • Fibrin coating, foul smelling wounds heavily colonised by germs: 20 minutes
ActiMaris® Wound Irrigation Solution forte

Before using ActiMaris® Wound Irrigation Solution forte, the wounds should first be rinsed with ActiMaris® Wound Irrigation Solution sensitive and cleaned to remove dirt and easily removable layers. Subsequent deep cleansing and odour reduction is then carried out with ActiMaris® Wound Irrigation Solution forte. For this purpose, inert dressings or wound dressings soaked with the Wound Irrigation Solution are used. The application can take place in the form of the classic moist dry phase (according to G. Kammerlander). The recommended length of the moist phase is 5-10 minutes for wounds that are heavily fibrinous or purulent, infected or highly foul-smelling. After the wound condition has improved, it is recommended to use ActiMaris® Wound Irrigation Solution sensitive for further wound cleansing until the wound is visibly clean.

ActiMaris® Wound Gel

Before applying the ActiMaris® Wound Gel, the wound should be cleaned with ActiMaris® Wound Irrigation Solution. The ActiMaris® Wound Gel is then generously applied onto or into the wound and covered with an inert dressing.

Valid for all ActiMaris® products

The length of time and frequency of application must be adapted to the state of the individual wound and should be carried out until all coverings and necrosis can be easily removed and the wound is visibly clean. Depending on the wound, the dressing can be changed every 2 to 3 days for non-infected wounds according to indication and phase. In cases where dressings are difficult to remove, we recommend wetting the wound dressings with ActiMaris® Wound Irrigation Solution for at least 5 minutes until the dressings can be gently removed without traumatising the wound surfaces. In the case of thick, firmly adhering fibrinous or necrotic wound dressings, primary surgical sanitation is recommended.

ActiMaris® Wound Gel is suitable for filling deep wounds alone or in combination with an alginate or hydrofibre dressing.

Yes, ActiMaris® can be used with catheters, entry ports and PEG tubes (see package insert). Firstly, the entry site and tubes should be disinfected with ActiMaris®forte”. Afterwards, it is recommended to apply ActiMaris® Wound Gel to the tube to improve lubrication and minimise pain.

For ActiMaris® SENSITIVE Wound Irrigation Solution, ActiMaris® FORTE Wound Irrigation Solution and ActiMaris® Wound Gel there are no restrictions regarding the duration of use. ActiMaris® products are indicated for long-term and repeated use. After improvement of the wound condition, ActiMaris® FORTE Wound Irrigation Solution it can be switched to ActiMaris® SENSITIVE Wound Irrigation Solution.

General questions

Yes. ActiMaris® has several advantages over saline and Ringer’s solution (see point: Uses of ActiMaris®). However, the use of ActiMaris® is also advantageous from an economic point of view, especially where smaller quantities are called for. This can be explained by the long period of use of 3 months once
ActiMaris® products have been opened. ActiMaris® can be stored at room temperature and generally used without preheating. In comparison, saline and Ringer’s solution should be discarded after 24 hours at the latest, and stored in a cool place.