SilverStream® is a patented wound management solution, combining a low concentration of silver ions, menthol and glycerol plus a surfactant, dissolved in a hypertonic solution. SilverStream's innovative synergetic formulation ensures effective anti-bacterial preservative activity. The high concentration of the hygroscopic glycerol provides hydrogel properties. SilverStream effectively cleans, moisturizes and soothes chronic and hard-to-treat wounds. The specialized synergistic combination of silver ions and menthol reduces the concentration level of the silver ions - to well below the cytotoxic threshold.
How does SilverStream close wounds faster?
SilverStream's effectiveness has been tested by Nelson Labs – USA for the following characteristics:
SilverStream's Anti-Biofilm effectiveness has been tested by Montana CBE – USA
SilverStream® has been authorized as a medical device by the US FDA, the CDSCO (Indian FDA) and the Israeli MOH for the management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations.
SilverStream is a clear, neutral pH hypertonic aqueous solution, which helps in the mechanical removal of foreign material including dirt and debris, exudates and microorganisms from the application site. It serves as a liquid dressing by providing a physical barrier against outside bacterial contamination. SilverStream is cleared by the US FDA as a medical device (K093227) due to its physical mode of action described in the following section:
SilverStream may be administered by pouring the solution directly from the bottle, applying by means of a syringe or bulb, spraying onto the wound using a spray bottle, applying with devices designed to allow for irrigation or lavage, or by pouring onto a gauze/dressing or sponge for cleansing and dressing the wound. Typically, the SilverStream solution is applied via a syringe with 19-22G needle, which creates a pressure between 4-15 psi over the wound bed. Thus, the methods of application of SilverStream allow for the mechanical removal of foreign material.
Primarily, foreign materials are mechanically removed through irrigation, from the application site, as the fluid moves across the wound bed (flushing action). The surfactant in the solution reduces the surface tension and thereby additionally assists with the mechanical removal of foreign material. The hypertonic nature of the solution (containing 10%V/V glycerol) further supports the mechanical removal of bacteria and foreign material by the physical withdrawal of liquids (liquids absorption), which is also supported by the hygroscopic properties of glycerol. In addition, due to its humectant properties, glycerol helps to moisturize the wound bed/application site.
SilverStream solution contains a low concentration ionic silver (0.01%), which acts as a preservative, to control the growth of bacteria, yeast and fungi such as Eschericha coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger.
Menthol is included in the solution, at a concentration of 0.05%, which is below the lowest active concentration for topical use (0.08%) and is intended to provide pleasant odor to the solution and to fight the bad odor of the wounds.
After cleansing the wound, SilverStream soaked gauze is applied on or into the wound to provide a physical barrier against outside bacterial contamination.
In summary, the SilverStream solution is designed to achieve its medical device primary mode of action (PMoA); primarily, the mechanical streaming of the hypertonic solution across the wound surface for removal of foreign objects, including dirt, debris and micro-organisms, as well as being applied as a physical barrier from outside bacterial contamination, supported by its preservative property to prevent wound contamination.
SilverStream® is a hypertonic buffered solution, with hydrogel properties and a pleasant odor, for wound management and maintenance of wound moisture level. SilverStream® is a clear, colorless solution, protected from microbial contamination by a low concentration of ionic silver and supplied in 100mL, 250mL and 500mL bottles. The 500mL bottles are also available with seuptum closure, to be used in combination with NPWT systems.
INTENDED USE AND INDICATIONS FOR USE
SilverStream® is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations.
GENERAL DIRECTIONS FOR USE
SilverStream® is designed for management and moisturizing of wounds by applying the SilverStream® solution directly from the bottle, by means of a syringe or bulb, spraying onto the wound using a spray bottle, by applying with devices designed to allow for irrigation or lavage.
Apply 1-2 times daily; up to 700 mL per day or according to physician's instructions.
Following SilverStream® application, the wound can be rinsed with water or water and soap.
Note: The wound may be cleansed if SilverStream® is applied with a 19G needle (application pressure of ~ 10 psi).
CAUTIONS AND WARNINGS
Store the bottle between 10-30ºC.
The empty bottle can be disposed of in a regular trash can. A bottle that contains solution should be disposed of in an appropriate site.
Ingredients include purified water, glycerol (glycerin), sorbitan monolaurate (Tween-20), TRIS, menthol and silver nitrate 0.01% (w/v).
Each package contains twenty four (24) bottles 100mL or twelve (12) bottles of 250mL or 500mL The instructions for use leaflet is part of the bottle label.
Instructions for use attached SilverStream® is a hypertonic buffered solution, with hydrogel properties and a pleasant odor, for wound management and maintenance of wound moisture level.
SilverStream® is a clear, colorless solution, protected from microbial contamination by a low concentration of ionic silver and menthol. The Product is supplied in 100mL, 250mL and 500mL bottles.
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