Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair.
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.
Cosgrove
G Rees
GR
Massachusetts General Hospital, Boston, Massachusetts, USA. g.rees.cosgrove@lahey.org
Delashaw
Johnny B
JB
Grotenhuis
J Andre
JA
Tew
John M
JM
Van Loveren
Harry
H
Spetzler
Robert F
RF
Payner
Troy
T
Rosseau
Gail
G
Shaffrey
Mark E
ME
Hopkins
L Nelson
LN
Byrne
Richard
R
Norbash
Alex
A
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
D014014:Tissue Adhesives; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate