Tisseel® versus Hemopatch® for dural sealing in neurosurgery. A prospective study in a tertiary center

Neurochirurgie. 2020 Dec;66(6):429-434. doi: 10.1016/j.neuchi.2020.09.008. Epub 2020 Oct 19.

Abstract

Background: Dural repair is a potential source of complications in neurosurgery. We make a comparison in pseudomeningocele and CSF leak incidence with the sealants Tisseel® and Hemopatch®.

Methods: We collected 147 patients from September 2017 to December 2018 in a prospective observational study. Inclusion criteria were adult patients with an intradural cranial or spinal surgery whose dura was closed with a fibrin sealant. Primary endpoints were the incidence of pseudo meningocele and CSF leak. Secondary endpoints were the surgical-site infection, epidural hematoma, and the influence of previous surgery.

Results: In 65 and 82 patients Tisseel® and Hemopatch® were used as sealants respectively. The incidence of CSF leak presented a significant statistical relation with the use of Tisseel® in a univariate and multivariate analysis. Infratentorial surgery presented a higher incidence of pseudomeningocele and CSF leak, but the approach used was not a significant factor in multivariate analysis. Patients who were operated previously had a higher risk present a postoperative complication.

Conclusions: The incidence of pseudomeningocele and CSF leak was higher with Tisseel® compared with Hemopatch® with a statistic significant relation in case of CSF fistulae. The procedure done may be a confusion factor in our study. There was no report of adverse effects or a higher incidence of complications. However, it is recommended to plan randomized trials with larger samples to get stronger evidence.

Keywords: CSF leak; Fibrin sealant; Hemopatch®; Pseudomeningocele; Tisseel®.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Bandages*
  • Cerebrospinal Fluid Leak / epidemiology
  • Cerebrospinal Fluid Leak / prevention & control
  • Dura Mater / surgery*
  • Female
  • Fibrin Tissue Adhesive
  • Humans
  • Incidence
  • Male
  • Meningocele / epidemiology
  • Meningocele / prevention & control
  • Middle Aged
  • Neurosurgical Procedures / methods*
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control
  • Prospective Studies
  • Surgical Wound Infection / epidemiology
  • Tertiary Care Centers
  • Treatment Outcome
  • Young Adult

Substances

  • Fibrin Tissue Adhesive