DEVELOPMENT OF A NEXT-GENERATION ANTIMICROBIAL WOUND DRESSING.

Abstract

Delayed wound healing due to infection is a burden on healthcare systems, and the patient and caregiver alike. An emerging factor in infection and delayed healing is the presence development of biofilm in wounds. Biofilm is communities of microorganisms, protected by an extracellular matrix of slime in the wound, which can tolerate host defences and applied antimicrobials such as antibiotics or antimicrobial dressings. A growing evidence base exists suggesting that biofilm exists in a majority of chronic wounds, and can be a precursor to infection while causing delayed healing itself. In vivo models have demonstrated that the inflammatory, granulation and epithelialization processes of normal wound healing are impaired by biofilm presence. The challenge in the development of a new antimicrobial wound dressing was to make standard antimicrobial agents more effective against biofilm, and this was answered following extensive biofilm research and testing. A combination of metal chelator, surfactant and pH control displayed highly synergistic anti-biofilm action with 1.2% ionic silver in a carboxymethylcellulose dressing. Its effectiveness was challenged and proven in complex in vitro and in vivo wound biofilm models, followed by clinical safety and performance demonstrations in a 42-patient study and 113 clinical evaluations. Post-market surveillance was conducted on the commercially available dressing, and in a 112-case evaluation, the dressing was shown to effectively manage exudate and suspected biofilm while shifting difficult-to-heal wounds onto healing trajectories, after an average of 4 weeks of new dressing use in otherwise standard wound care protocols. This was accompanied by a low frequency of dressing related adverse events. In a second evaluation, clinical signs of infection and wound dimension data, before and after the evaluations, were also available. Following an average of 5.4 weeks of dressing use, all signs of clinical infection were reduced, from an average frequency of 36% to 21%. An average of 62% wound size reduction was achieved, with 90% of wounds reducing in size and 10 wounds healing completely. The new clinical evidence for this next-generation antimicrobial wound dressing suggests it is safe and effective at managing exudate, infection and biofilm, while it can shift established, stubborn wounds onto healing trajectories. The scientific rationale for this new dressing technology is supported by in vitro and in vivo evidence, so now further comparative, randomized and outcome-based clinical studies are required to fully understand the clinical and economic benefits this new dressing technology can bring.