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. 2016 Apr 27;11(4):e0151533. doi: 10.1371/journal.pone.0151533

Table 2. Article Inclusion and Exclusion Criteria.

Inclusion Criteria Exclusion Criteria
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.
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.
Cost data reports without efficacy or safety data
Reviews, editorials, opinions, comments, and letters without original data.
Non-clinical (ie, experimental, animal, or in vitro) studies.
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.
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.
or had spinal tap procedures with persistent CSF leaks.
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.
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.
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.
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.
Medical treatment with acetazolamide.
Conservative treatment with persisting CSF leak
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).
2. After CSF Leak: a) the number of patients with effective closure of the CSF leak
Safety Outcome Measures Could include (but not limited to):
Mortality.
Overall incidence of serious adverse events (quantitative).
Overall incidence of adverse events related to fibrin sealants (quantitative).
Qualitative assessment of specific adverse events/serious adverse events related to use of fibrin sealants.
Reoperation rate due to CSF leaks.