Abstract
Objective: Adhesion formation is a negative outcome of sinus surgery and common cause for revision surgery. Chitosan has been approved by the Food and Drug Administration for use in hemorrhage control. We hypothesized that a chitosan-based compound may be beneficial in sinus surgery for reduction in adhesion formation.
Method: NovaGen, a sprayable-gel formulation consisting of chitosan and starch derivatives was developed. To support a premarket submission to the FDA of a medical device, we examined efficacy of adhesion reduction by NovaGen in vitro, in an experimental rabbit peritoneal adhesion model and an experimental sheep sinus adhesion model.
Results: In an experimental wound migration model of cultured human fibroblasts, NovaGen led to significant inhibition of fibroblast migration at 24.
Conclusion: NovaGen, a novel, chitosan-based compound, reduced cultured human fibroblast migration, reduced adhesions by 75% in a rabbit model, reduced adhesions by 70% in a sheep sinus adhesion model, and demonstrated no discernible side effects. These data support NovaGen’s novel use in human sinus surgery for hemostasis and reduction in adhesion formation.
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