Safety and performance of surgical adhesives.

Abstract

Tissue adhesives are an alternative to conventional surgical sutures to reduce the time and cost of wound closure and to improve patient comfort. The use of tissue adhesives does not require any subsequent intervention and significantly lowers the volume and rate of blood loss, and reduces the need for transfusions during and after surgery. However, based on their formulation, tissue adhesives' safety profile and functional properties may differ. Therefore, this study aimed to evaluate the basic safety and performance of NE'X Glue® Surgical Sealant, BioGlue® Surgical Sealant, and PREVELEAKTM Surgical Sealant in vitro. The basic safety of commercially available tissue adhesives was evaluated using MEM elution assay according to ISO 10993-5 and endotoxin level according to 85. USP. The in vitro performance was evaluated using lap-shear by tension loading test, burst strength test, degradation, and swelling assays. NE'X Glue®, BioGlue®, and PREVELEAKTM did not cause cytotoxicity in MEM elution assay. All surgical adhesives are below the general limit of endotoxin contamination of 20 EU/device. NE'X Glue® and BioGlue® showed the highest and comparable strength properties in lap shear and burst strength tests compared to PREVELEAKTM. NE'X Glue® and PREVELEAKTM are characterized by lower degradation potential than BioGlue®. PREVELEAKTM is characterized by the highest swelling when compared to NE'X Glue® and BioGlue®. NE'X Glue® is most versatile in terms of functional properties while maintaining the same safety profile as BioGlue® and PREVELEAKTM.