Dural repair with four spinal sealants: focused review of the manufacturers' inserts and the current literature.

BACKGROUND CONTEXT: Deliberate or traumatic dural fistulas are typically augmented by a "sealant" or "fibrin glue" to enhance the strength of dural closure.
PURPOSE: Little is known about the risks and complications associated with two specific "sealants" and two specific "fibrin glues" used for dural closure. STUDY DESIGN/
SETTING: 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. PATIENT SAMPLE: A focused review of the literature using four different "sealants" or "fibrin glues" was performed. OUTCOME MEASURES: 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.
CONCLUSION: 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.