Test results

Biocompatibility

Bactiguard Wound Care/Hydrocyn aqua solution has been tested for biocompatibility as per ISO 10993 & has passed following in-vivo and in-vitro studies.

Biocompatibility TestResult
Acute Dermal Toxicity StudyNo dermal toxicity
In Vivo Studies; Intracutaneous Reactivity TestNo evidence of erythema or oedema
In Vivo Studies; Primary Skin TestNo skin irritation
Genotoxicity StudiesNo genotoxicity effect
Cytotoxicity StudiesNo cytotoxic effect
Acute Oral Toxicity StudyNo oral toxicity
Skin Sensitization StudyNon-sensitizing
Ocular Irritation StudyNo ocular irritation
Vaginal Irritation StudyNo vaginal irritation
Acute Inhalation Toxicity StudyNo toxicity
All tests done under GLP conditions and reported as per international norms.

Antimicrobial effect

Bactiguard Wound Care/Hydrocyn aqua 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 ans spores.*

MicroorganismsMicrobial Presence
Bacteria
Escherichia coliND (<1)
Bacillus cereusND (<1)
Pseudomonas aeruginosaND (<1)
Enterococcus faecalisND (<1)
Salmonella sp.ND (<1)
Salmonella typhimuriumND (<1)
Staphylococcus aureusND (<1)
Listeria sp.ND (<1)
Legionella sp.ND (<1)
Pseudomonas putidaND (<1)
Fungi
Aspergillus nigerND (<1)
Yeast & moldND (<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, VRE99.99%
MRSA99.99%
Mycobacterium bovis99.99%
Gardnerella vaginalis99.99%
Acinetobacter baumannii99.99%
Klebsiella pneumoniae99.99%
Klebsiella pneumoniae, CRE99.99%
Fungi
Candida albicans99.99%
Trichophytan mentagrophytes
99.99%
Sporothrix schenckii99.99%
Candida auris99.99%
Spores
Bacillus subtilis99.99%
Clostridium difficile99.99%
Clostridium sporogenes98.45%

Effective against biofilm

In vitro tests show that Bactiguard Wound Care/Hydrocyn aqua solution is effective against biofilm (Pseudomonas aeruginosa and MRSA) and reduces biofilm concentration up to 99,9 %.

Biofilm typeResult
Pseudomonas AeruginosaThe 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.