title: Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair.
abstract: OBJECTIVE
  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.
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts, USA. g.rees.cosgrove@lahey.org
authors.forename: G Rees
authors.initials: GR
authors.lastname: Cosgrove
authors.forename: Johnny B
authors.initials: JB
authors.lastname: Delashaw
authors.forename: J Andre
authors.initials: JA
authors.lastname: Grotenhuis
authors.forename: John M
authors.initials: JM
authors.lastname: Tew
authors.forename: Harry
authors.initials: H
authors.lastname: Van Loveren
authors.forename: Robert F
authors.initials: RF
authors.lastname: Spetzler
authors.forename: Troy
authors.initials: T
authors.lastname: Payner
authors.forename: Gail
authors.initials: G
authors.lastname: Rosseau
authors.forename: Mark E
authors.initials: ME
authors.lastname: Shaffrey
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.forename: Richard
authors.initials: R
authors.lastname: Byrne
authors.forename: Alex
authors.initials: A
authors.lastname: Norbash
mesh_terms: D000328:Adult; D000368:Aged; D001927:Brain Diseases / Q000601:surgery*; D004388:Dura Mater / Q000473:pathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013536:Suture Techniques; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014014:Tissue Adhesives; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate