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

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.
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