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  • Title: Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair.
    Author: Cosgrove GR, Delashaw JB, Grotenhuis JA, Tew JM, Van Loveren H, Spetzler RF, Payner T, Rosseau G, Shaffrey ME, Hopkins LN, Byrne R, Norbash A.
    Journal: J Neurosurg; 2007 Jan; 106(1):52-8. PubMed ID: 17236487.
    Abstract:
    OBJECT: The 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. METHODS: The 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. CONCLUSIONS: The 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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