Types of Studies |
Randomized controlled trials evaluating the efficacy of fibrin sealants in dura sealing. Non-randomized, controlled trials reporting efficacy were allowed provided that the scope of the research was to evaluate the effect of fibrin sealants in dura sealing. |
Minor case series/case reports with <20 patients. |
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All evidence levels, including case reports, that including safety data were acceptable for safety analysis inclusion. |
Case series where different surgical techniques (including technical notes) are compared rather than the potential effects of fibrin sealants. |
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Cost data reports without efficacy or safety data |
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Reviews, editorials, opinions, comments, and letters without original data. |
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Non-clinical (ie, experimental, animal, or in vitro) studies. |
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Clinical trials with major quality issues and a high risk of bias were excluded from efficacy analysis, but could be included in safety analyses. |
Types of Participants |
Patients (irrespective of age, sex or race) who: a) had undergone neurosurgical intervention of the brain or spine where fibrin sealants had been used to seal dura in order to treat acute CSF leaks and/or to prevent CSF leaks |
Patients with spontaneous or trauma-related CSF leaks. |
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or presented with persistent CSF leaks after neurosurgical procedures where conservative treatment had failed and where attempts to close the CSF leak using fibrin sealants had been done |
Patients where fibrin sealant was used for haemostatic effect only. |
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or had spinal tap procedures with persistent CSF leaks. |
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Types of Interventions |
Fibrin sealant either as liquid glue (drops or spray) or solid dry patch applied to: a) acute CSF leak after surgery as an add-on treatment covering the suture lines |
Fibrin sealants mixed with other products such as bone chips/powder, hydroxyapatite etc. |
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b) acute CSF leak from dural patch of autologous fascia, pericranium or collagen-based dura substitute to cover the suture lines and patch. |
Comparisons of different fibrin sealant application methods. |
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c) persistent CSF leak after neurosurgical procedures and spinal puncture |
Interventions where fibrin sealant is not applied on or close to dura/dura grafts or suture lines involving dura to provide dura sealing. |
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Reports on the sole use of autologous/homemade fibrin sealants (non-standardized product characteristics). |
Types of comparators |
Placebo (sham) or no fibrin sealant treatment (just sutures). |
Studies where different patches/dura substitutes are compared and fibrin sealants are used as the standard of care. |
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Medical treatment with acetazolamide. |
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Conservative treatment with persisting CSF leak |
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Types of Efficacy Outcome Measures |
Could include (but not limited to): 1. After Surgery: a) acute CSF leaks (preferably after Valsalva maneuver to increase intracranial pressure); b) Early (1 week) persistent CSF leaks (β2-transferrin, computed tomography or magnetic resonance imaging); or c) Late (>4 weeks) persistent CSF leaks (β2-transferrin, computed tomography or magnetic resonance imaging). |
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2. After CSF Leak: a) the number of patients with effective closure of the CSF leak |
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Safety Outcome Measures |
Could include (but not limited to): |
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Mortality. |
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Overall incidence of serious adverse events (quantitative). |
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Overall incidence of adverse events related to fibrin sealants (quantitative). |
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Qualitative assessment of specific adverse events/serious adverse events related to use of fibrin sealants. |
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Reoperation rate due to CSF leaks. |
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