Abstract
Object. 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 428-433 |
| Number of pages | 6 |
| Journal | Journal of neurosurgery |
| Volume | 112 |
| Issue number | 2 |
| DOIs | |
| State | Published - Jan 1 2010 |
| Externally published | Yes |
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Keywords
- Dural closure
- Dural sealant
- Duraplasty
- Hydrogel
ASJC Scopus subject areas
- Surgery
- Clinical Neurology
Cite this
The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials : Clinical article. / Weinstein, Jason S.; Liu, Kenneth C.; Delashaw, Johnny B.; Burchiel, Kim J.; Van Loveren, Harry R.; Vale Diaz, Fernando; Agazzi, Siviero; Greenberg, Mark S.; Smith, Donald A.; John, Tew.
In: Journal of neurosurgery, Vol. 112, No. 2, 01.01.2010, p. 428-433.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials
T2 - Clinical article
AU - Weinstein, Jason S.
AU - Liu, Kenneth C.
AU - Delashaw, Johnny B.
AU - Burchiel, Kim J.
AU - Van Loveren, Harry R.
AU - Vale Diaz, Fernando
AU - Agazzi, Siviero
AU - Greenberg, Mark S.
AU - Smith, Donald A.
AU - John, Tew
PY - 2010/1/1
Y1 - 2010/1/1
N2 - Object. 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.
AB - Object. 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.
KW - Dural closure
KW - Dural sealant
KW - Duraplasty
KW - Hydrogel
UR - http://www.scopus.com/inward/record.url?scp=76149140476&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=76149140476&partnerID=8YFLogxK
U2 - 10.3171/2009.6.JNS081540
DO - 10.3171/2009.6.JNS081540
M3 - Article
C2 - 19645538
AN - SCOPUS:76149140476
VL - 112
SP - 428
EP - 433
JO - Journal of Neurosurgery
JF - Journal of Neurosurgery
SN - 0022-3085
IS - 2
ER -