Test results

Biocompatibility

Bactiguard Wound Care/Hydrocyn aqua solution has shown no toxic effect in the biocompatibility test shown below, ISO 10993 and has passed the 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.*

Microorganisms% Reduction
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)

Effective against biofilm

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

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%
Bacillus subtilis99.99%
Clostridium difficile99.99%
Clostridium sporogenes98.45%
Spores
Trichophytan mentagrophytes99.99%
Sporothrix schenckii99.99%
Candida auris99.99%

*Tested using ASTM E2315-03 (Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure)
** ND: Not Detected