The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials

Clinical article

Jason S. Weinstein, Kenneth C. Liu, Johnny B. Delashaw, Kim Burchiel, Harry R. Van Loveren, Fernando L. Vale, Siviero Agazzi, Mark S. Greenberg, Donald A. Smith, Tew John

Research output: Contribution to journalArticle

37 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)428-433
Number of pages6
JournalJournal of Neurosurgery
Volume112
Issue number2
DOIs
StatePublished - Feb 2010

Fingerprint

Meningitis
Safety
Surgical Wound Infection
Equipment and Supplies
Hydrogel
Incidence
Ambulatory Surgical Procedures
Population Groups
Population
Multicenter Studies
Cohort Studies
Collagen
Retrospective Studies

Keywords

  • Dural closure
  • Dural sealant
  • Duraplasty
  • Hydrogel

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

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; Van Loveren, Harry R.; Vale, Fernando L.; Agazzi, Siviero; Greenberg, Mark S.; Smith, Donald A.; John, Tew.

In: Journal of Neurosurgery, Vol. 112, No. 2, 02.2010, p. 428-433.

Research output: Contribution to journalArticle

Weinstein, JS, Liu, KC, Delashaw, JB, Burchiel, K, Van Loveren, HR, Vale, FL, Agazzi, S, Greenberg, MS, Smith, DA & John, T 2010, 'The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials: Clinical article', Journal of Neurosurgery, vol. 112, no. 2, pp. 428-433. https://doi.org/10.3171/2009.6.JNS081540
Weinstein, Jason S. ; Liu, Kenneth C. ; Delashaw, Johnny B. ; Burchiel, Kim ; Van Loveren, Harry R. ; Vale, Fernando L. ; Agazzi, Siviero ; Greenberg, Mark S. ; Smith, Donald A. ; John, Tew. / The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials : Clinical article. In: Journal of Neurosurgery. 2010 ; Vol. 112, No. 2. pp. 428-433.
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