Frequently Asked Questions (FAQs)
APPLICATION
Simple, natural and effective. The product is an all-in-one spray for the wound bed, wound edge and the peri-wound skin.
WOUND can be used for all acute and chronic wounds, as well as minor skin wounds and burns. Regardless of a dry, moist or wet wound environment.
Yes. But WOUND should only be used on non-absorbable stitches. Absorbable stiches might be resolved too fast, as WOUND brings additional moisture to the wound situation.
Yes, as far as the seam material is not resorbable. Otherwise it might trigger that the stiches are resorbed too fast.
We have not observed any contraindications in any wounds.
Minimum: We advise to spray until an oil layer is visible (minimally 2 puffs/layers on the same area).
As a general rule: rather use too much than too little oil, in order to minimize the risk that the secondary dressing adheres to the wound (observed in situation where too little oil was applied, or no oil was re-applied for >48 hours).
– Because of its fine texture the ideal secondary dressing is a simple non woven gauze (e.g. Cutisoft from BSN)
Appr. 90% of cases
– In case of an exudating wound an absorbent dressings (i.e. foam) is recommended.
Appr. 5-10% of cases
– In case of strong exudation, a superabsorbent secondary dressing is recommended (e.g. Sorbion Sachet).
Appr. 1-3% of cases
Yes, provided the dressing material is made for a daily change. Modern wound care products are often too expensive for a daily change. Therefore, we recommend a simple non woven gauze (see Herzig 174 consecutive patients).
Yes, but the secondary dressing has to adjusted to the wound exudate.
This is to be decided by the treating health care professional. In general, wounds are covered with a secondary dressing, which is adjusted to the wound exudate. In most cases, a simple non-woven dressing is sufficient.
No, the oil film is semi-occlusive (which is specific to natural oils if compared to synthetic oils/fats due to the shorter chains of the molecules of natural oils).
Consequently, important gases like oxygen can come into the wound, but exudate and bacteria can get out of the wound into the secondary dressing.
No. This is not necessary.
No, clinically there is no risk if the oil comes in contact with exposed structures (see e.g. the Läuchli cases, where the product is sprayed directly on exposed bone).
Yes. Ideally, let the oil penetrate the wound for approx. 1 to 2 minutes, before covering with the secondary dressing.
No, the combination of the oils has pure physical effects.
MODE OF ACTION
– Creation of a moist wound environment.
– The secondary dressing does not adhere to the wound. This reduces pain and skin trauma.
– Anti-microbial effect without cytotoxic side effect
– Protection of a healthy skin function, protection of the wound edges and peri-wound skin from maceration.
Both oils have traditionally been used in wound healing. The mix of Neem and Hypericum shows an ideal profile of fatty acids, which acts synergistically. A corresponding patent has been filed and granted to the WOUND spray in 2006. In addition, both oils have a good skin care effect.
The wound surface and secondary dressing are separated through a water rejecting (hydrophobic) oil layer. But please use sufficient oil (2 layers).
The oil layer is rejecting water (hydrophobic), therefore the moisture stays in the wound and prevents/prolongs the evaporation of the water molecules that are in the wound (see e.g. internal vapor water evaporation rate study).
The fatty acids have a bacteriolytic effect. WOUND is even anti-microbial, meaning besides the anti-bacterial effect there is also an anti-mycotic effect (thanks to Neem oil).
The free fatty acids cover the bacterium cell wall, which can no longer uptake nutrients and oxygen. Hence, the bacteria’s slowly die with a lysis of their cell walls, but in gentle way without releasing endotoxins.
“WOUND” was tested in vitro (conservation stress test – USP 51 test) against:
– Pseudomonas aeroginosa (log5 in 2 days)
– Staphylococcus aureus (log5 in 7 days)
– Candida albicans (log5 in 2 days)
– Aspergillus niger (log5 in 2 days)
Log 5 reduction means the time needed to reduce the amount of bacteria from 100’000 to 1. (Logarithm of 5 = 10*10*10*10*10).
The oil is being absorbed by the body. The uptaken oil is like food for the newly formed cells and extracellular matrix.
Yes, through lipid synthesis. The fatty acids build the skin barrier in the intercellular and surrounding area of the wound. Maceration is also prevented.
Yes, since March 2018, the product can be used also in children as of 1 months of age (see details on package insert).
Which is your main competitor, which product can be replaced?
The main advantage of the product is, that it is part of a simple treatment concept (together with a simple non-woven gauze), that endorses self-treatment. In addition, it is possible to address all the important prerequisites of modern wound care and all locations (wound bed, edge and peri-wound skin) with one product. There is no 1-1 competitor with the same properties.
WOUND creates a wound environment which helps the system to accelerate the physiological wound healing process. Various cases have shown a positive effect on angiogenesis.
WOUND creates a wound environment in which physiological wound healing gets activated. Clinical experience often shows an increase of granulated tissue.
INGREDIENTS
The mode of action of the product is based on the physical properties of the oil film and its fatty acids.
For the CE registration, the product was tested for irritation and sensitization (delayed-type hypersensitivity test). All results were negative. During the Post Marketing Surveillance, an allergic reaction to the product was reported in 5 of 280 cases. All the patients reporting an allergic reaction suffered from multiple allergies.
Antidepressant drugs using St. John’s Wort are taken orally, and used systemically based on concentrated alcoholic extracts of Hypericin. WOUND is topically applied and does not show a pharmacological relevant concentration of hypericin.
No, the concentration of hypericin in WOUND is far too low to have this effect. Note: Antidepressants made out of St. John’s Wort oil are taken orally, and are based on concentrated alcoholic extract of Hypericin in factors higher concentration than present in WOUND.
WOUND does not have pharmacologically active ingredients. The effects of WOUND are based on a physical mode of action.
WOUND is not a certified as an organic product. However, no pesticides are used and no pesticides can be detected in residue analyses.
CONTRA-INDICATIONS
Yes, but after radiation treatment is finalized, in order to treat the radiation related wound situation. The product should not be used during radiation treatment, as the oil film on the wound could lead to a situation where even more heat is conserved by the body.
No, not if the wound is covered by a secondary dressing.
SHELF LIFE / STORAGE
Do not use after the expiry date marked on the spray and carton (the shelf life is 42 months, 36 months in Zone IV countries).
The used propellants propane/butane are natural and nontoxic gases which catabolize into CO2.
No. Due to the fact that the spray contains propellants, air cannot penetrate into the spray. Furthermore, WOUND has anti-microbial properties and is self-preserving.
Even after first use, WOUND is still stable and can be used until the expiry date indicated on the packaging.
Only for a very short moment, as they evaporate quickly.
All the purity regulations of the European Pharmacopoeia are met. The product did not go through sterilization, but is self-preserving. No increase of bugs seen during stability testing throughout the shelf life.
REGISTRATION
The category is Medical Device class IIb (and registered as Class C in Vietnam)
Yes, it has been demonstrated that there is no evidence of skin irritation, sensitivity or cell toxicity.