Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures

Completed · Phase 3

Conditions studied: Elective Cranial Procedures With Dural Incision

In brief

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.

Key facts

Study ID

NCT01158378

Run by

HyperBranch Medical Technology, Inc

People needed

250

Starts

2010-06-01

Expected to finish

2013-01-01

Last updated by the study team

2014-04-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Colorado Brain and Spine Institute/Swedish Medical Center — Englewood, Colorado, United States
• Florida Hospital — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Wayne State University — Detroit, Michigan, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Carolina Neurosurgery & Spine Associates — Charlotte, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• Mayfield Clinic — Cincinnati, Ohio, United States
• Oklahoma Spine and Brain Institute — Tulsa, Oklahoma, United States
• Penn State University Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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