Preclinical Evaluation of CuraVue ® : A Novel Dual-Action Antimicrobial Silicone Adhesive Securement Dressing

Abstract Background Catheter-related bloodstream infections (CRBSIs) are among the most important challenges facing health care workers, leading to morbidity and mortality all over the world. CuraVue® is an antimicrobial adhesive securement dressing loaded with Chlorhexidine and Silver that is designed to offer sustained broad-spectrum antimicrobial activity over 7 days, thus proving it to be an efficient dressing at vascular access and device insertion sites, allowing reduction of the incidence of CRBSIs. Results Seven antimicrobial studies were carried out to assess CuraVue® antimicrobial activity, namely Disc Diffusion Testing (CLSI M02), Quantitative Contact-kill Test (ISO 22196), Quantitative Time-kill Test over 7 Days (Modified ISO 22196), Minimum Inhibitory Concentration (MIC) Detection, Static Coupon Biofilm Assay (ASTM E3435), assessment of Chlorhexidine and Silver Spatial Uniformity Distribution, and In Vivo Evaluation of Antimicrobial Efficacy in a Rat Skin Abrasion Colonization Model. Disc diffusion testing showed measurable zones of inhibition against all tested strains. The ISO 22196 contact-kill assay showed ≥ 99.99% reduction against all tested organisms, with exceptional activity against P. aeruginosa (R = 6.00). The 7-day time-kill assay gave mean R values ≥ 4.0 for S. aureus , E. coli , and P. aeruginosa , with no significant decline over time (linear regression, p > 0.05). MIC testing showed bacterial inhibition. The biofilm assay demonstrated strong antibiofilm activity (> 99% inhibition against the three tested strains). Spatial uniformity testing confirmed consistent antimicrobial activity across all regions of the dressing. An ISO-certified testing laboratory validated CuraVue® antimicrobial activity, showing > 5.22 log and > 5.12 log reductions against E. coli and S. aureus, respectively, confirming its strong, sustained antimicrobial efficacy. In the rat skin abrasion colonization model, CuraVue® significantly reduced bacterial burden compared to the negative control. Conclusions CuraVue® demonstrated broad-spectrum and sustained antimicrobial activity throughout the 7 day wear period supported by antibiofilm formation activity and localized microbial suppression on skin surface as proven in an in vivo animal model. These results indicate that CuraVue® should be considered as an effective antimicrobial protective dressing for vascular access and device insertion sites.