title: Evaluation of fibrin sealants for central nervous system sealing in the mongrel dog durotomy model.
abstract: BACKGROUND
  Watertight repair of the dura is imperative after neurosurgical procedures involving the brain or spinal cord because inadequately treated leakage of cerebrospinal fluid (CSF) from punctured dura can have serious consequences such as meningitis, arachnoiditis, or epidural abscess.
  
  
  OBJECTIVE
  To assess the efficacy of Evicel Fibrin Sealant (Human) to prevent CSF leakage using a 2.0-cm durotomy mongrel dog repair model and to compare the tissue response with Tisseel (a fibrin sealant) and Duraseal (a synthetic polyethylene glycol [PEG] hydrogel sealant).
  
  
  METHODS
  The canine durotomy repair model was used. This well-characterized model assesses the ability of sealants to achieve intraoperative watertight seals of the dura mater, as well as long-term safety and efficacy. This study included 27 mongrel dogs and had a 28-day duration.
  
  
  RESULTS
  The 3 sealants were 100% effective in preventing CSF leakage intraoperatively at 15 mm Hg. The 2 fibrin sealants were 100% effective in postoperative sealing; the PEG hydrogel was not. Microscopically, the tissue changes induced by Evicel at the durotomy site were similar in nature except for foamy macrophages seen only with the PEG hydrogel. The extent and severity of adhesions at 28 days were less with the fibrin sealants than with the PEG hydrogel.
  
  
  CONCLUSIONS
  Evicel, a fibrin sealant, was safe and effective in achieving and maintaining a watertight seal of the dura. The performance of the fibrin sealants was similar to that of the synthetic PEG hydrogel sealant with the exception of a Duraseal seal, which leaked.
authors.affiliation: Ethicon, Inc, a Johnson & Johnson Company, Somerville, NJ, USA. rhutchin@its.jnj.com
authors.forename: Richard W
authors.initials: RW
authors.lastname: Hutchinson
authors.forename: Vince
authors.initials: V
authors.lastname: Mendenhall
authors.forename: Randolph M
authors.initials: RM
authors.lastname: Abutin
authors.forename: Tim
authors.initials: T
authors.lastname: Muench
authors.forename: James
authors.initials: J
authors.lastname: Hart
mesh_terms: D000818:Animals; D065634:Cerebrospinal Fluid Leak; D002559:Cerebrospinal Fluid Rhinorrhea / Q000517:prevention & control*; D003399:Craniotomy / Q000379:methods*; D004195:Disease Models, Animal; D004285:Dogs; D004388:Dura Mater / Q000601:surgery*; D005337:Fibrin / Q000627:therapeutic use*; D015718:Fibrin Tissue Adhesive / Q000494:pharmacology*; D008297:Male; D000267:Tissue Adhesions / Q000517:prevention & control; D014945:Wound Healing / Q000187:drug effects
chemical_list: D015718:Fibrin Tissue Adhesive; D005337:Fibrin