Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
Condition: Elective Cranial Procedures With Dural Incision
MeSH terms: Surgical Wound
Intervention: Adherus Dural Sealant
Intervention description: In situ polymerizing sealant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Adherus Dural Sealant; Adherus AutoSpray Dural Sealant

Summary:

      The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural
      Sealant System when used as a dural sealant in conjunction with standard methods of dural
      repair in cranial procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-Operative Inclusion Criteria

          -  Subject is scheduled for an elective cranial procedure involving a dural incision
             using any of the following surgical locations/approaches (or combination): frontal,
             temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral
             suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class
             1/clean wound (uninfected surgical wound in which no inflammation is encountered)

        Intra-Operative Inclusion Criteria

          -  Subject's linear extent of durotomy is ≥2 cm

          -  Subject's dural margins from the edges of bony defect are ≥3 mm throughout

          -  Subject's CSF leak is present intra-operatively following completion of primary dural
             closure (with or without non-autologous duraplasty or autologous tissue), either
             spontaneously or upon Valsalva maneuver, at up to 20 cm H2O for up to five (5) seconds

        Exclusion Criteria:

          -  Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral
             approach, or any procedure that penetrates the air sinus or mastoid air cells. Note:
             Superficial penetration of mastoid air cells is not an exclusion if cells are
             appropriately sealed (e.g. bone wax).

          -  Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural,
             ventriculo-atrial or lumbo-peritoneal shunts.

          -  Subject has an external ventricular or lumbar CSF drain that must be left in place
             after surgery.

          -  Subject has had radiation treatment to the surgical site, or standard fractionated
             radiation therapy is planned within ten days post index-procedure. (Note: stereotactic
             radiosurgery prior to the planned index procedure is not an exclusion criterion).

          -  Subject has a systemic infection or evidence of any infection near planned operative
             site.

        Intra-Operative Exclusion Criteria

          -  Subject has an Incidental finding that meets any pre-operative exclusion criterion
             listed above.

          -  Subject requires the intra-operative placement of a CSF diversion device (e.g.
             ventricular catheter, subdural catheter, lumbar drain, or other device designed to
             externally evacuate CSF) that will be left in place after the procedure. Note:
             Subgaleal drains used for acute post-operative management of the incision site are
             permitted.