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Evidence-Based Practice
Antimicrobial agents within wound care provide topical alternatives to manage infection. Antimicrobials cause cell death of micro-organisms so the concentration of the agents need to be controlled for patient safety as all antimicrobials, including silver, will cause toxicity at high levels. PHMB (polyhexamethylene biguanide)is a broad-spectrum antimicrobial substance used in contact lens cleaning solutions, peri-operative cleansing products, swimming pool cleaners and more recently, wound care dressings.
PHMB wound care options are growing in the market, therefore it is important to understand the the safety profile of this antimicrobial agent.
Methods:
Biological safety testing, in-vitro testing and literature review has been performed to assess the safety and efficacy of PHMB.
Results:
PHMB Foam Silicone Border was assessed for biological safety in accordance with ISO 10993-1. The results conclude this PHMB Foam Silicone Border is non-cytotoxic, non-sensitising and non-irritating indicating low risk of causing local tissue response and an implantation study showed no signs of toxicity.
A study by Kramer et al showed no evidence of mutagenicity or carcinogenicity in either in-vivo or in-vitro testing.
The in-vitro Scratch model showed that fibroblast cells exposed to PHMB Silicone Foam were able to close the scratch wound, and performed similarly to the control sample after 24hrs.
Discussion:
The biological safety testing and literature review confirm that Silicone PHMB Foam range is safe to use in wound care and are considered ‘one of the best possible choices’ for wound therapy.
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