A multicenter, prospective, randomized clinical study to evaluate the efficacy and safety of fibrin sealant as an adjunct to sutured dural repair

The two-sided 95% CI for the difference in success rates using the Normal approximation Z (pooled) statistic was 37.3% and 59.9%. Since the lower limit of the CI is >0, it is concluded that the success rate in the Bioseal group is significantly higher than the suture group. The incidence of CSF leakage post discharge to 30 (±7) days observed in this study was 0.8% in the Bioseal group and 1.6% in the control group, while the study by Green et al[5] reported CSF leak rates of 2.2% in the FS group vs. 2.0% in the control group. [...]the incidence of SSIs in this trial was extremely low in both groups (0.7% for Bioseal vs. 0 for sutures), whereas the observed incidence of SSIs in the previous study with human FS (EVICEL) was 1.1% in the FS group vs. 2.0% in the control group. [...]only the subjects were blinded to the treatment, while investigators were not, which may result in some biases. [...]the results of this study strongly support the use of Bioseal as an adjunctive sealant to sutured dural repair by showing a markedly increased success rate compared with the control (suture alone). [...]Bioseal may be considered a superior treatment option to sutures alone for the prevention of CSF leakage, with a favorable safety profile.