GELATIN-ALGINATE SURGICAL SEALANT LOADED WITH HEMOSTATIC AGENTS

The purpose of this study is to investigate the ability of natural-polymers solutions crosslinked by carbodiimides for biocompatible and hemostatic surgical sealant application.

Our novel surgical sealants are based on the natural polymers gelatin and alginate, crosslinked by carbodiimide. Two types of hemostatic agents with a layer silicates structure, montmorillonite (MMT) and kaolin were loaded in order to improve the sealing ability in a hemorrhagic environment. The effect of the sealant`s components on the in vitro burst strength was studied according to ASTM F2392, the physical properties (swelling ratio, degradation, viscosity, curing time) and cytotoxicity were investigated as well.

A formulation based on 400 mg/ml gelatin, 10 mg/ml alginate and 15 mg/ml EDC was found as an optimal one, combining high burst strength together with no cytotoxicity. Incorporation of kaolin only slightly affected the sealant physical properties. When the maximal kaolin concentration of 50 mg/ml was used the burst strength was increased in 38% compared to unloaded sealant. In contrast, incorporation of MMT significantly affected the crosslinked polymeric system and improved the sealants properties. Loading of 5 and 20 mg/ml MMT increase the in vitro burst strength in 43% and 108%, in respectively. Unloaded sealant and kaolin/MMT Loaded sealants didn’t show any cytotoxicity effects. The curing time of all sealant formulations was in the range of 5-10 seconds, which is suitable for surgical sealants.

This research clearly shows that our novel formulations of gelatin-alginate crosslinked by carbodiimide have a promising potential to be used in surgical sealing applications. Furthermore, the incorporation of kaolin and MMT in gelatin-alginate surgical sealants is a very promising novel approach for improving the bonding strength and physical properties of the surgical sealants for use in hemorrhagic environments.