PHMB: Assessment of Safety

Topical antimicrobials are becoming a preference in infection management given the known resistance problems to long term use of antibiotics and are used regularly in the management of wound bioburden. is one option in the management of wound bioburden. This poster looks to understand the toxicity profile of this substance.

Biological safety testing and literature review has been performed to assess the toxicological safety of using PHMB

PHMB has two speculated modes of actions- disruption of bacterial membranes, and disruption of chromosomes in bacteria due to bacteria having no nuclei to protect its genetic material (unlike mammalian cells).
A sub-cutaneous implantation study conducted over 30days reviewed body weight; clinical observations; haematology; clinical chemistry; coagulation parameters; organ/relative organ weights and macroscopic and microscopic evaluation of implant sites and selected organs
Literature searches have revealed that the is a very high 200mg/kg/bodyweight/day, and that in a study of chronic intake of 100mg/kg/bodyweight/day for two years no adverse reactions were seen demonstrating high tolerance for the compound1.
A study by showed no evidence of mutagenicity or carcinogenicity in either in-vivo or in-vitro testing, and Willenegger2 determined with detectability of 10ppm that no uptake of the compound could be proven by skin or wounds suggesting that the body does not actively absorb the compound.
When reviewing the 3 compared to their performance against E.coli and S.aureus PHMB was noted to outperform PVP iodine, chlorhexidine and triclosan.

Biological safety testing and literature review confirm that PHMB devices are safe to use in wound care over a prolonged contact duration, and that the second suggested mode of action alludes to PHMB being ‘selective’ to bacterial cells and unable to affect mammalian cells.

Trademarked Items (if applicable):

References (if applicable): 1)Hübner et al Skin Pharmacol Physiol 2010;23(suppl 1):17–27
2) Willenegger, H. Lokale Antiseptika in der Chirurgie-Wiedergeburt und Weiterentwicklung. Unfallchirurgie 20, 94–110 (1994).
3)Müller and Kramer Journal of Antimicrobial Chemotherapy (2008) 61, 1281–1287
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