Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair
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.
Medical Subject Headings
Adult; Aged; Brain Diseases (surgery); Dura Mater (pathology, surgery); Female; Follow-Up Studies; Humans; Hydrogel, Polyethylene Glycol Dimethacrylate (therapeutic use); Male; Middle Aged; Prospective Studies; Suture Techniques; Tissue Adhesives (therapeutic use); Treatment Outcome
Journal of neurosurgery
Digital Object Identifier (DOI)
Cosgrove, G Rees; Delashaw, Johnny B.; Grotenhuis, J Andre; Tew, John M.; Van Loveren, Harry; Spetzler, Robert F.; Payner, Troy; Rosseau, Gail; Shaffrey, Mark E.; Hopkins, L Nelson; Byrne, Richard; and Norbash, Alex, "Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair" (2007). Neurosurgery. 1753.