Gelatin-alginate surgical sealant loaded with hemostatic agents
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1
Tel-Aviv University, Department of Materials Science and Engineering, Faculty of Engineering, Israel
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2
Tel-Aviv University, Department of Biomedical Engineering, Faculty of Engineering, Israel
Introduction: Various medical devices were developed in the last few decades providing solutions in the medical field of wound closer. They are divided into three groups of devices: (a) Hemostats- formed blood (b) Adhesive-attached tissue together. (c) Sealant- creates a sealing barrier that prevents the leakage of gas or liquid from a structure, usually from wound tissues or suture lines (cardiovascular or gastro). Adhesive and sealants are in situ self-polymerized and are most effective in dry area. The goal of this study is to investigate the ability of natural-polymer solutions crosslinked by carbodiimides to function as biocompatible and hemostatic surgical sealants.
Materials and Methods: Our novel surgical sealants are based on the natural polymers gelatin (porcine, type A) and alginate, crosslinked by carbodiimide (EDC). 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. The sealant was applied using a double chamber syringe with static mixer in a 4:1 volume ratio which provide a consistent mixing of the polymers and crosslinker solutions.
Results and Discussion: 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 (in concentration range of 10-50 mg/ml) only slightly affected the sealant physical properties. When the maximal kaolin concentration of 50 mg/ml (8:1 Polymers : Kaolin ratio) 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. Despite of the high affinity of MMT to water, its incorporation in the sealant (20 mg/ml) reduced the degradation rate and the swelling ratio in 25%, probably due to its homogenous dispersion in the crosslinked polymeric network. Also, the MMT layers probably well interact with the natural polymers, gelatin and alginate, and this prevents the MMT interaction with the aqueous medium. 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. Although both hemostatic agents exhibit layered silicate structure, the differences between the MMT and kaolin in the polymeric system is derived from the expansion abilities of the MMT. It can form nanocomposite structure in contradiction to the unexpanded kaolin which forms microcomposite structure.
Conclusion: This research clearly demonstrates that our novel formulations of gelatin-alginate crosslinked by carbodiimide are of promising potential to be used in surgical sealing applications. Furthermore, the incorporation of kaolin and MMT in these sealants is a very promising novel approach for improving the bonding strength and physical properties of the surgical sealants for use in hemorrhagic environments.
Keywords:
nanocomposite,
Biocompatibility,
Polymeric material
Conference:
10th World Biomaterials Congress, Montréal, Canada, 17 May - 22 May, 2016.
Presentation Type:
Poster
Topic:
Adhesive biomaterials
Citation:
Pinkas
O and
Zilberman
M
(2016). Gelatin-alginate surgical sealant loaded with hemostatic agents.
Front. Bioeng. Biotechnol.
Conference Abstract:
10th World Biomaterials Congress.
doi: 10.3389/conf.FBIOE.2016.01.01171
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Received:
27 Mar 2016;
Published Online:
30 Mar 2016.
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Correspondence:
Dr. Oded Pinkas, Tel-Aviv University, Department of Materials Science and Engineering, Faculty of Engineering, Tel-Aviv, Israel, Email1
Dr. Meital Zilberman, Tel-Aviv University, Department of Materials Science and Engineering, Faculty of Engineering, Tel-Aviv, Israel, meitalz@post.tau.ac.il