Work

Polyethylene glycol-coated patch versus standard dural sealing practices for preventing cerebrospinal fluid leaks in posterior fossa surgery: a randomized multicenter study

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: BACKGROUND: This study evaluated the efficacy and safety of the polyethylene glycol (PEG)-coated patch as a dural sealant in elective non-traumatic posterior fossa surgeries (nTPFS) requiring dural closure. METHODS: This multicenter, randomized, controlled phase-IV study was conducted, between January and December 2022, on adult patients who underwent nTPFS requiring dural opening and closure. Patients were randomized to receive either PEG-coated patch reinforcement or standard sealing. The primary endpoint was the incidence of clinically evident cerebrospinal fluid (CSF)-leakage within four weeks post-intervention. RESULTS: A total of 121 patients were included, 57(47.1%) in the PEG-coated patch group and 64(52.9%) in the standard sealing group. No statistically significant differences were observed in the primary endpoint of clinically evident CSF leak (12.3% vs. 9.4%; incidence rate difference: 2.9%; 95%CI: -8.7% to 14.6%; p = 0.606). Secondary outcomes were also comparable between groups, including pseudomeningocele (24.6% vs. 20.3%; p = 0.575), hospital readmissions (12.3% vs. 9.4%; p = 0.606), surgical site infections (5.3% vs. 4.7%; p = 0.884), and adverse events (22.8% vs. 20.3%; p = 0.739). Two patients, one in each group, experienced serious adverse events classified as "hospitalization or prolonged stay." Most adverse events were mild to moderate and resolved with standard medical management. CONCLUSIONS: The PEG-coated patch, alone or with fibrin sealant, demonstrated comparable efficacy in preventing CSF leak compared to multiple product combinations. The study does not demonstrate superiority, but shows a reassuring safety profile and similar rates of secondary outcomes, including pseudomeningocele, hospital readmissions, surgical site infections and adverse events, in both groups. These findings support the PEG-coated patch as a safe dural sealing option in elective non-traumatic posterior fossa surgery, while potential workflow or economic advantages remain to be formally evaluated in future studies.

Source: Neurochirurgie

DOI: 10.1016/j.neuchi.2026.101777