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

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  • 1 Massachusetts General Hospital, Boston, Massachusetts
  • 2 Oregon Health Sciences University, Portland, Oregon
  • 3 Radboud University Medical Center, Nijmegen, The Netherlands
  • 4 University of Cincinnati, Mayfield Clinic, Cincinnati, Ohio
  • 5 University of South Florida, Tampa General Hospital, Tampa, Florida
  • 6 Barrow Neurological Institute, Phoenix, Arizona
  • 7 Indianapolis Neurosurgical Group, Inc., Indianapolis, Indiana
  • 8 Chicago Institute of Neurosurgery and Neuroresearch, Chicago, Illinois
  • 9 University of Virginia Health Systems, Charlottesville, Virginia
  • 10 Department of Neurosurgery, Millard Fillmore Gates Circle Hospital, University at Buffalo, New York
  • 11 Rush University Medical Center, Chicago, Illinois and
  • 12 Boston Medical Center, Boston, Massachusetts
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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.

Abbreviations used in this paper:CSF = cerebrospinal fluid; CT = computed tomography; FDA = Food and Drug Administration; PEG = polyethylene glycol.

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Contributor Notes

Address reprint requests to: G. Rees Cosgrove, M.D., Department of Neurosurgery, Lahey Medical Center, 41 Mall Road, Burlington, Massachusetts 01805 email: g.rees.cosgrove@lahey.org.
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