Test results
Biocompatibility
Hydrocyn aqua / Bactiguard Wound Care solution has been tested for biocompatibility as per ISO 10993 & has passed following in-vivo and in-vitro studies.
BIOCOMPATIBILITY TEST | RESULT |
Acute Dermal Toxicity Study | No dermal toxicity |
In Vivo Studies; Intracutaneous Reactivity Test | No evidence of erythema or oedema |
In Vivo Studies; Primary Skin Test | No skin irritation |
Genotoxicity Studies | No genotoxicity effect |
Cytotoxicity Studies | No cytotoxic effect |
Acute Oral Toxicity Study | No oral toxicity |
Skin Sensitization Study | Non-sensitizing |
Ocular Irritation Study | No ocular irritation |
Vaginal Irritation Study | No vaginal irritation |
Acute Inhalation Toxicity Study | No toxicity |
Antimicrobial effect
Hydrocyn aqua / Bactiguard Wound Care has been tested on several microorganisms following the ASTM E2315 standard test. The tests show that the product is effective against both gram-positive and gram-negative bacteria (including MRSA), fungi and spores.*
Microorganisms | Microbial Presence |
Bacteria | |
Escherichia coli | ND (<1) |
Bacillus cereus | ND (<1) |
Pseudomonas aeruginosa | ND (<1) |
Enterococcus faecalis | ND (<1) |
Salmonella sp. | ND (<1) |
Salmonella typhimurium | ND (<1) |
Staphylococcus aureus | ND (<1) |
Listeria sp. | ND (<1) |
Legionella sp. | ND (<1) |
Pseudomonas putida | ND (<1) |
Fungi | |
Aspergillus niger | ND (<1) |
Yeast & mold | ND (<1) |
*Tested using ASTM E2315-03 (Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure)
** ND: Not Detected
Time-kill evaluation (60 sec of exposure)
Microorganisms | % Reduction |
Bacteria | |
E. feacalis, VRE | 99.99% |
MRSA | 99.99% |
Mycobacterium bovis | 99.99% |
Gardnerella vaginalis | 99.99% |
Acinetobacter baumannii | 99.99% |
Klebsiella pneumoniae | 99.99% |
Klebsiella pneumoniae, CRE | 99.99% |
Fungi | |
Candida albicans | 99.99% |
Trichophytan mentagrophytes | 99.99% |
Sporothrix schenckii | 99.99% |
Candida auris | 99.99% |
Spores | |
Bacillus subtilis | 99.99% |
Clostridium difficile | 99.99% |
Clostridium sporogenes | 98.45% |
Effective against biofilm
In vitro tests show that Hydrocyn aqua / Bactiguard Wound Care solution is effective against biofilm (Pseudomonas aeruginosa and MRSA) and reduces biofilm concentration up to 99,9 %.
Biofilm type | Result |
Pseudomonas Aeruginosa | The result shows a log reduction of more than 5.95 from the initial biofilm concentration and effectively reduced biofilm by 99.9%. |
Methicillin-resistant Staphylococcus aureus (MRSA) | The result shows a log reduction of more than 4.4 from the initial biofilm concentration and effectively reduced biofilm by 99,99%. |
The test was carried out demonstrate ASTM E2799-12, Standard Test Method for Testing Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC Assay. Data on file.
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