title: Dural repair with four spinal sealants: focused review of the manufacturers' inserts and the current literature.
abstract: BACKGROUND
  Deliberate or traumatic dural fistulas are typically augmented by a "sealant" or "fibrin glue" to enhance the strength of dural closure.
  
  
  OBJECTIVE
  Little is known about the risks and complications associated with two specific "sealants" and two specific "fibrin glues" used for dural closure.
  
  
  METHODS
  Review of the manufacturers' inserts and a focused review of the literature concerning the pros and cons for two "sealants" (DuraSeal [Confluent Surgical Inc., Waltham, MA, USA] and BioGlue [Cryolife, Kennesaw, GA, USA]) and two "fibrin glues" (EVICEL [Johnson and Johnson Wound Management, Ethicon Inc., Somerville, NJ, USA] and Tisseel [fibrin sealant; Baxter International Inc., Westlake Village, CA, USA]) were assessed.
  
  
  METHODS
  A focused review of the literature using four different "sealants" or "fibrin glues" was performed.
  
  
  METHODS
  Documentation of persistent/recurrent postoperative cerebrospinal fluid fistulas was an end point for failure for the four different "sealants" and "fibrin glues."
  
  
  METHODS
  Manufacturers' inserts and a focused review of the literature concerning the relative safety and efficacy of two "sealants" (DuraSeal and BioGlue) and two "fibrin glues" (EVICEL and Tisseel) used to augment dural closure were assessed.
  
  
  RESULTS
  Although DuraSeal is approved by the Federal Drug Administration (FDA) for intracranial and spinal application, two instances of paralysis are described in the literature. BioGlue is classified by the manufacturer as neurotoxic. EVICEL, one of the "fibrin glues," appeared in just two animal studies, whereas Tisseel, the other "fibrin glue," has been used in many large clinical series without adverse events.
  
  
  CONCLUSIONS
  Despite the lack of FDA approval, Tisseel (fibrin glue) has seen wide adoption in "off-label" use. DuraSeal, which is FDA approved, was associated with two instances of paralysis. Alternatively, BioGlue was described as neurotoxic even by the manufacturer.
authors.affiliation: The Leo M. Davidoff Department of Neurological Surgery, The Albert Einstein College of Medicine, Bronx 10461, NY, USA. dch3@columbia.edu
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Epstein
mesh_terms: D004388:Dura Mater / Q000601:surgery*; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D011506:Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012117:Resins, Synthetic / Q000009:adverse effects / Q000627:therapeutic use; D014014:Tissue Adhesives / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: C472676:Bio-glue; D015718:Fibrin Tissue Adhesive; D011506:Proteins; D012117:Resins, Synthetic; D014014:Tissue Adhesives; C030189:Dura-Seal