Posterior fossa surgeries present significant challenges in achieving a watertight dural closure due to anatomical complexity and the frequent need for dural substitutes. These procedures carry a particularly elevated risk of cerebrospinal fluid (CSF) leakage or ingress of blood and air, likely due to residual tissue planes [[1], [2], [3], [4], [5], [6], [7], [8]].
Effective dural closure is critical to prevent these complications, infections, and the introduction of irritating blood products into the CSF [9,10]. However, since perfect closure is often unachievable, adjunctive dural sealants have become standard practice to reduce CSF-related complications.
CSF leak rates vary considerably, ranging from 0.8% to 32%, depending on surgical variables and patient factors such as age, immune status, and comorbidities [[11], [12], [13], [14], [15]]. Posterior fossa procedures are associated with particularly high leakage incidence (15–28%), representing a 5.84-fold increased risk compared to supratentorial surgeries [3].
Postoperative CSF leak may present as pseudomeningocele or the more severe CSF fistula, a major surgical complication [16]. Large pseudomeningoceles sometimes require secondary surgical intervention [14].
Watertight dural closure is a key goal in neurosurgery. Various techniques and materials are used, including meticulous suturing, lumbar drainage, autologous grafts, dural substitutes, and sealants such as fibrin glue, BioGlue®, DuraSeal®, Gelfoam®, DuraGen®, TissuePatchDural®, and Tachosil® [[1], [2], [3], [4], [5], [6], [7], [8],[17], [18], [19]]. In endoscopic skull base surgery, where suturing is difficult or unfeasible, alternative strategies are essential [1,2,4,[20], [21], [22], [23]]. Fibrin-based sealants are particularly effective in reinforcing closures and sealing suture holes, especially under high intracranial pressure [1,2,4,[20], [21], [22], [23]].
Although available data support the use of sealants in posterior fossa surgeries, variability in study populations and pathologies limits generalizability [[1], [2], [3], [4], [5], [6], [7], [8],[17], [18], [19], [20], [21], [22], [23]]. Future studies with selective inclusion criteria and specific pathology populations may yield more precise and generalizable results.
The polyethylene glycol (PEG)-coated patch (Hemopatch®, Sealing Haemostat, Baxter AG, Vienna, Austria) is a self-adhering surgical device with hemostatic and sealing capabilities [24]. Its adhesive surface uses a rapid protein-reactive monomer to form covalent amide bonds with tissue proteins and collagen, ensuring effective tissue integration [24]. The PEG-coated patch has demonstrated substantial potential as a dural sealant in cranial neurosurgery, effectively minimizing postoperative CSF leaks [[24], [25], [26], [27], [28], [29]].
Published clinical data support the PEG-coated patch's efficacy in achieving watertight dural closure, particularly when suturing is insufficient. CSF leak rates as low as 1.68% have been reported without significant adverse effects [29]. In a prospective series of 200 high-risk patients, leak rates decreased from 27% to 7% after two years of technique refinement, with no product-related complications [30]. A recent retrospective cohort study reported significantly lower CSF fistula rates with the PEG-coated patch (7.69%) compared with standard methods (32.65%) (p < 0.0001) [31].
While these results highlight the strong safety and efficacy profile of the PEG-coated patch, randomized controlled trials are necessary to confirm these findings and support broader clinical adoption.
This multicentric and prospective study aimed to evaluate the effectiveness and safety profile of a PEG-coated patch as a dural sealant in patients undergoing elective non-traumatic posterior fossa surgery requiring dural incision and closure. The trial provides prospective multicenter safety and effectiveness data through a pragmatic design, with the principal contribution being demonstration of comparable efficacy in preventing CSF leak when compared with standard sealing techniques.
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