Proposed phase 2/ step 2 in-vitro test on basis of EN 14561 for standardised testing of the wound antiseptics PVP-iodine, chlorhexidine digluconate, polihexanide and octenidine dihydrochloride

BMC Infect Dis. 2017 Feb 13;17(1):143. doi: 10.1186/s12879-017-2220-4.

Abstract

Background: Currently, there is no agreed standard for exploring the antimicrobial activity of wound antiseptics in a phase 2/ step 2 test protocol. In the present study, a standardised in-vitro test is proposed, which allows to test potential antiseptics in a more realistically simulation of conditions found in wounds as in a suspension test. Furthermore, factors potentially influencing test results such as type of materials used as test carrier or various compositions of organic soil challenge were investigated in detail.

Methods: This proposed phase 2/ step 2 test method was modified on basis of the EN 14561 by drying the microbial test suspension on a metal carrier for 1 h, overlaying the test wound antiseptic, washing-off, neutralization, and dispersion at serial dilutions at the end of the required exposure time yielded reproducible, consistent test results.

Results: The difference between the rapid onset of the antiseptic effect of PVP-I and the delayed onset especially of polihexanide was apparent. Among surface-active antimicrobial compounds, octenidine was more effective than chlorhexidine digluconate and polihexanide, with some differences depending on the test organisms. However, octenidine and PVP-I were approximately equivalent in efficiency and microbial spectrum, while polihexanide required longer exposure times or higher concentrations for a comparable antimicrobial efficacy.

Conclusion: Overall, this method allowed testing and comparing differ liquid and gel based antimicrobial compounds in a standardised setting.

Keywords: Bactericidal efficacy; Chlorhexidine digluconate; EN 14561; Octenidine dihydrochloride; PVP-iodine; Polyhexanide; Wound antisepsis; Yeasticidal efficacy.

MeSH terms

  • Anti-Infective Agents, Local / pharmacology*
  • Biguanides / pharmacology
  • Chlorhexidine / analogs & derivatives
  • Chlorhexidine / pharmacology
  • Enterococcus faecium / drug effects*
  • Humans
  • Imines
  • In Vitro Techniques*
  • Microbial Sensitivity Tests / methods*
  • Microbial Sensitivity Tests / standards*
  • Microbial Viability / drug effects
  • Povidone-Iodine / pharmacology
  • Pseudomonas aeruginosa / drug effects*
  • Pyridines / pharmacology
  • Staphylococcus aureus / drug effects*
  • Time Factors

Substances

  • Anti-Infective Agents, Local
  • Biguanides
  • Imines
  • Pyridines
  • polihexanide
  • Povidone-Iodine
  • chlorhexidine gluconate
  • octenidine
  • Chlorhexidine