Open AccessNovaGen Reduces Adhesions In Vitro and in 2 In Vivo Models
Author(s) -
Das Subinoy,
Medina Jennifer G.,
Steinke John W.
Publication year - 2011
Publication title -
otolaryngology–head and neck surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.232
H-Index - 121
eISSN - 1097-6817
pISSN - 0194-5998
DOI - 10.1177/0194599811416318a269
Subject(s) - adhesion , in vivo , in vitro , fibroblast , chitosan , surgery , hemostasis , chemistry , pharmacology , medicine , biochemistry , biology , microbiology and biotechnology , organic chemistry
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.