• Journal of neurosurgery · Jan 2007

    Multicenter Study Clinical Trial

    Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair.

    • G Rees Cosgrove, Johnny B Delashaw, J Andre Grotenhuis, John M Tew, Harry Van Loveren, Robert F Spetzler, Troy Payner, Gail Rosseau, Mark E Shaffrey, L Nelson Hopkins, Richard Byrne, and Alex Norbash.
    • Massachusetts General Hospital, Boston, Massachusetts, USA. g.rees.cosgrove@lahey.org
    • J. Neurosurg. 2007 Jan 1;106(1):52-8.

    ObjectThe authors prospectively evaluated the safety and efficacy of a novel polyethylene glycol (PEG) hydrogel sealant in patients undergoing elective cranial surgery with documented cerebrospinal fluid (CSF) leakage after sutured dural repair.MethodsThe PEG hydrogel sealant was used at 11 different study sites in 111 patients with documented intraoperative CSF leakage after neurosurgical dural repair for a variety of conditions. Intraoperative CSF leakage was either spontaneous or induced by a Valsalva maneuver. Patients were monitored for 3 months postoperatively with physical examinations, clinical laboratory analyses, and diagnostic imaging. The PEG hydrogel sealant was 100% effective in stopping CSF leakage in all patients. There were no sealant-related adverse events and all clinical outcomes were consistent with expectations for seriously ill patients undergoing prolonged neurosurgical procedures.ConclusionsThe PEG hydrogel sealant provides a safe and effective watertight closure when used as an adjunct to sutured dural repair during cranial surgery.

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