The use of dural sealant patches for reinforcement of durotomy repair: a systematic review.

Objective: Dural sealant patches (DSPs) are a useful adjunct when closing the dura during cranial or spinal surgery to avoid cerebrospinal fluid (CSF) leakage or infection. Authors of this paper systematically review the outcomes and incidence of CSF leakage and infection with the use of a DSP versus conventional practice.

Methods: The MEDLINE, Embase, Cochrane Library, and Scopus databases were searched, and clinical trials and prospective or retrospective case-control and cohort studies with a low-risk of bias and involving any solid DSP used in adults for cranial or spinal cases were included. Studies that used a DSP in combination with another method of dural sealant closure, used a DSP as a dural substitute rather than an adjunctive closure device, or used hydrogel or polymer gel (i.e., nonsolid) dural sealant "patches" were excluded. A meta-analysis of comparative studies reporting outcomes relating to CSF leakage was performed together with a subgroup analysis for each DSP type. For comparative studies reporting outcomes relating to infection, a separate meta-analysis was conducted.

Results: Across the 7 noncomparative studies included, 669 patients received TachoComb (n = 421, 1 study), TachoSil (n = 8, 1 study), Liqoseal (n = 40, 1 study), TissuePatchDural (n = 144, 2 studies), or Hemopatch (n = 56, 2 studies). Across the 6 comparative studies included, 1013 patients received TachoSil (n = 784, 3 studies), TissuePatchDural (n = 147, 2 studies), or Hemopatch (n = 82, 1 study). When considering the rates of CSF leakage or infection, 2/6 comparative studies found DSPs to be significantly more effective than current practice, while the remaining 4/6 demonstrated noninferiority compared to current practice. All studies considered the DSPs to be safe. A meta-analysis revealed significant improvements in the incidence of CSF leakage with the use of a DSP overall, but the improvements in CSF leak rates for the TachoSil and TissuePatchDural subgroups did not reach statistical significance. The single study evaluating Hemopatch did find statistically significant improvements in CSF leak rates. There were no significant differences in infection between the DSP groups.

Conclusions: There was a significant improvement in the incidence of CSF leaks with the use of DSPs. Comparisons among DSP types and evaluations of outcomes relating to infection should be the focus of further research in this area.