Comparison of Poly-N-acetyl Glucosamine (P-GlcNAc) with Absorbable Collagen (Actifoam), and Fibrin Sealant (Bolheal) for Achieving Hemostasis in a Swine Model of Splenic Hemorrhage

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Abstract

Objective:

To compare the hemostatic capabilities of poly-N-acetylglucosamine (p-GlcNAc) with three currently available products: Actifoam, Surgicel, and Bolheal fibrin glue. This study was conducted in a controlled animal model, with monitoring of hematologic parameters over the course of the study. Two series were conducted, one in unheparinized animals comparing Bolheal fibrin sealant, Actifoam (absorbable collagen, AC), and Surgicel (ORC) with p-GlcNAc, and the second in systemically heparinized animals comparing p-GlcNAc with AC.

Methods:

This study was performed in immature female Yorkshire White swine. Splenic lacerations controlled for length and depth of wound were used as sources of bleeding, with one material used per wound to assess hemostatic effectiveness. A total of 97 wounds in 12 animals were created for the study, 74 wounds in unheparinized animals, and 23 wounds in the heparinized animals. In the heparinized animals, hemostatic efficacy was judged by number of applications needed to achieve complete hemostasis. In the unheparinized animals, hemostatic efficacy was judged by length of time required to achieve complete hemostasis (p-GlcNAc vs. fibrin sealant) or the number of applications needed to achieve complete hemostasis (p-GlcNAc vs. AC or ORC).

Results:

In systemically heparinized animals, p-GlcNAc demonstrated greater hemostatic efficacy (72.7%) in one application than did the control material (0%), p < 0.01. In the unheparinized animals, p-GlcNAc took less time to achieve hemostasis (mean, 22.9 seconds) than fibrin sealant (mean, 172.9 seconds), p < 0.01. p-GlcNAc achieved hemostasis with a greater efficacy (79.2%) in one application than did the AC or ORC (16.7%), p < 0.01, whereas there was no difference in the efficacy of the control materials.

Conclusion:

The results of the previous series in unheparinized animals demonstrated that p-GlcNAc in the form of a membrane is a more effective topical hemostatic agent than Bolheal fibrin glue, AC or ORC. The results in the anticoagulated animals similarly demonstrate that p-GlcNAc is a more effective topical hemostatic agent than the control material AC. These data indicate that p-GlcNAc is a promising hemostatic agent as evaluated in this model.

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