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

J Neurosurg. 2007 Jan;106(1):52-8. doi: 10.3171/jns.2007.106.1.52.

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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Brain Diseases / surgery*
  • Dura Mater / pathology
  • Dura Mater / 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

Substances

  • Tissue Adhesives
  • Hydrogel, Polyethylene Glycol Dimethacrylate