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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