The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials.
OBJECTIVE
The DuraSeal dural sealant system, a polyethylene glycol hydrogel, has been shown to be safe and effective when used with commercial and autologous duraplasty materials. The authors report on the safety and effectiveness of this sealant when used in conjunction with nonautologous duraplasty materials.


METHODS
In this retrospective, nonrandomized, multicenter study, the safety and efficacy of a dural sealant system was assessed in conjunction with primarily collagen-based nonautologous duraplasty materials in a sample of 66 patients undergoing elective cranial procedures at 3 institutions. This cohort was compared with 50 well-matched patients from the DuraSeal Pivotal Trial who were treated with this sealant system and autologous duraplasty material.


RESULTS
The key end points of the study were the incidences of CSF leaks, surgical site infections, and meningitis 90 days after surgery. The incidence of postoperative CSF leakage was 7.6% in the study group (retrospective population) and 6.0% in the Pivotal Trial population. The incidence of meningitis was 0% and 4.0% in the retrospective and Pivotal Trial groups, respectively. There were no serious device-related adverse events or unanticipated adverse device effects noted for either population.


CONCLUSIONS
This study demonstrates that the DuraSeal sealant system is safe and effective when used for watertight dural closure in conjunction with nonautologous duraplasty materials.
Weinstein
Jason S
JS
Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon 97239, USA.
Liu
Kenneth C
KC
Delashaw
Johnny B
JB
Burchiel
Kim J
KJ
van Loveren
Harry R
HR
Vale
Fernando L
FL
Agazzi
Siviero
S
Greenberg
Mark S
MS
Smith
Donald A
DA
Tew
John
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000627:therapeutic use*; D015331:Cohort Studies; D003094:Collagen; D003399:Craniotomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004388:Dura Mater / Q000601:surgery*; D017558:Elective Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004869:Equipment Safety; D005260:Female; D006801:Humans; D020100:Hydrogels / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D012189:Retrospective Studies; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D001672:Biocompatible Materials; D020100:Hydrogels; D014014:Tissue Adhesives; D011092:Polyethylene Glycols; D003094:Collagen