In Vitro Assessment of the Extended 21-Day Microbial Barrier Provided by the Exofin Fusion Surgical Incision Closure System.

Abstract

Background: Tissue adhesives are increasingly being used as alternatives to traditional sutures and staples in surgical incision closure applications. Exofin Fusion, a novel cyanoacrylate-based adhesive with a mesh, has been developed to enhance surgical incision closure. This study investigates the microbial barrier effectiveness of Exofin Fusion. Methods: An in vitro assessment of 35 plates, including challenge organisms, negative controls, and positive controls, was conducted by an independent research organization, North American Science Associates, Inc (NAMSA), USA. Exofin Fusion was applied to the plates aseptically. Each plate was then inoculated with specific challenge organisms. Observations for visible growth or color changes in the media were made over a 21-day period. Results: The results demonstrated no growth or color changes on test plates for common pathogens such as Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Aspergillus brasiliensis throughout the 21-day period. Candida albicans showed no growth or color changes up to day 20; however, two out of five replicates exhibited growth on day 21. Conclusions: The study confirms the microbial barrier properties of Exofin Fusion, as it effectively prevents the penetration of challenge organisms for the entire test period. Despite the growth of C. albicans in two replicates on day 21, the adhesive demonstrates remarkable efficacy in protecting against microbial infiltration. These findings suggest the potential clinical utility of Exofin Fusion in surgical incision closure applications, highlighting its significance in healthcare settings.