Neuro-Chirurgie · 2026
Polyethylene glycol-coated patch versus standard dural sealing practices for preventing cerebrospinal fluid leaks in posterior fossa surgery: a randomized multicenter study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Acitores Cancela Alberto, Pérez María Pérez, Martínez Luis González, Molina Jorge Díaz, López Laura Beatriz López, Picazo Sofía Sotos, Ataz Carmen Tudela, López Cristina Barcelo, Rial Básalo Juan Carlos, Ferreras Cristina, Álvarez Belén, Canal Adán Fernández, Ortega Jose Manuel, Piñeiro Jorge Bernal, Ramírez Yaiza López, Arias Carlos Alberto Rodríguez, Laez Rubén Martín, Gómez Patricia López, Ley-Urzaiz Luís
Аннотация
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.
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.