title: Effectiveness of Glycerol Mono-oleate as a Biosealant.
abstract: BACKGROUND
  The number of femoral artery catheterizations will increase over the next decade to more than 9 million worldwide. Accordingly, a new era of access site management with vascular closure techniques utilizing biologics are being developed and implemented. Glycerol mono-oleate (GMO) is one such biologic - a biodegradable compound that changes from a solid phase to a bioadhesive swollen semisolid phase when exposed to aqueous solutions and heat. We assessed whether GMO would: 1) achieve hemostasis more effectively than control when injected into a swine liver biopsy tract; and 2) inhibit common percutaneous procedure pathogens.
  
  
  METHODS
  During the hemostasis experiment, seven swine anticoagulated with heparin (ACT > 250) underwent 10 open-liver biopsies with a 14 gauge cutting needle; 5 injected with GMO (treatment) and 5 injected with nothing (control). Thirty seconds, 2 minutes, 5 minutes and 10 minutes after the procedure, bleeding was objectively graded; 0 = no bleeding (success) and 1 = bleeding (failure). During the bacteria experiment, GMO was injected into plates containing culture media for 4 common percutaneous pathogens (Enteroccocis faecalis, Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae). When injected, GMO converted to a semisolid phase with definitive margins in the culture media. Each bacterium was then coated over their respective media and GMO.
  
  
  RESULTS
  The results showed a significant treatment effect (p < 0.017) on each success/failure bleeding outcome at 30 seconds (p < 0.0001), 2 minutes (p < 0.0001) and 5 minutes (p = 0.0038) based on a multiple logistic regression analysis controlling for initial bleeding, pig and side-of-liver biopsy (medial or lateral lobe). At 10 minutes, the bleeding results were not significant (p = 0.0917), likely explained by a pig's innate ability to clot at this time period. For the bacteria experiment, there was no growth of bacteria on the GMO for any of the plates. Specifically, the Staphylococcus aureus plate displayed a 200 micron halo containing no bacterial growth surrounding the GMO.
  
  
  CONCLUSIONS
  In conclusion, these results illustrate a significant hemostatic effect post liver biopsy at multiple time points using GMO. Furthermore, GMO displays bacterial deterrent properties.
authors.affiliation: Department of Medicine, Duke University Medical Center, Box 2622, Durham, NC, 27710, USA.
authors.forename: George L
authors.initials: GL
authors.lastname: Adams
authors.forename: Roberto J
authors.initials: RJ
authors.lastname: Manson
authors.forename: Dana M
authors.initials: DM
authors.lastname: Giangiacomo
authors.forename: Lucy
authors.initials: L
authors.lastname: Fronheiser
authors.forename: Shannon
authors.initials: S
authors.lastname: McCall
authors.forename: Roger
authors.initials: R
authors.lastname: Nightingale
authors.forename: Vic
authors.initials: V
authors.lastname: Hasselblad
authors.forename: Linda K
authors.initials: LK
authors.lastname: Shaw
authors.forename: Luther
authors.initials: L
authors.lastname: Milton
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Lawson
mesh_terms: D020341:Absorbable Implants; D000818:Animals; D001672:Biocompatible Materials; D001707:Biopsy, Needle; D016063:Blood Loss, Surgical / Q000517:prevention & control; D004195:Disease Models, Animal; D005989:Glycerides / Q000494:pharmacology*; D006470:Hemorrhage / Q000517:prevention & control; D006489:Hemostatic Techniques; D006490:Hemostatics / Q000627:therapeutic use*; D008099:Liver / Q000601:surgery; D011336:Probability; D011897:Random Allocation; D012680:Sensitivity and Specificity; D013552:Swine; D014014:Tissue Adhesives / Q000494:pharmacology*
chemical_list: D001672:Biocompatible Materials; D005989:Glycerides; D006490:Hemostatics; D014014:Tissue Adhesives; C005953:monoolein