This is a prospective, multi-center, randomized, two arm, single blind study designed to assess if the Spinal Sealant System, when used as an adjunct to sutured dural repair, is more effective than standard of care methods for producing a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery.

The study site will conduct the spinal procedure according to the appropriate standard procedures and practices at his/her institution.  The sutured dural repair will be completed to the investigator’s satisfaction.  Autologous duraplasty materials (i.e., fascia, fat, pericranium, or muscle) may be used as necessary.  The use of synthetic, non-autologous dural substitutes, and/or blood-based sealants is not permitted.

Upon satisfactory completion of the sutured dural repair, the patient will be evaluated to confirm eligibility.  The dural repair will be evaluated for the presence or absence of a watertight closure with a baseline Valsalva maneuver at 20.25 cm H2O for 5-10 seconds.  If there is a spontaneous expression of cerebral spinal fluid (CSF), no Valsalva maneuver is required.  The type (i.e., overt versus seepage of CSF around the suture points) and nature of the non-watertight closure (i.e., spontaneous versus upon Valsalva) will be recorded.  If the patient meets all the intra-operative eligibility criteria, the patient will be randomized to either the Spinal Sealant arm or the control arm.  Randomization will be based on a 1:1 (sealant:control) ratio.  Patients that do not meet the intra-operative eligibility criteria will be withdrawn from the study without additional follow-up.