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Histological and magnetic resonance imaging assessment of Liqoseal in a spinal in vivo pig model

摘要Background : Liqoseal (Polyganics, B.V.) is a dural sealant patch for preventing postop-erative cerebrospinal fluid (CSF) leakage. It has been extensively tested preclinically and CE ( Conformité Européenne ) approved for human use after a first cranial in- human study. However, the safety of Liqoseal for spinal application is still unknown. The aim of this study was to assess the safety of spinal Liqoseal application compared with cranial application using histology and magnetic resonance imaging characteristics.Methods : Eight female Dutch Landrace pigs underwent laminectomy, durotomy with standard suturing and Liqoseal application. Three control animals underwent the same procedure without sealant application. The histological characteristics and im-aging characteristics of animals with similar survival times were compared to data from a previous cranial porcine model. Results : Similar foreign body reactions were observed in spinal and cranial dura. The foreign body reaction consisted of neutrophils and reactive fibroblasts in the first 3 days, changing to a chronic granulomatous inflammatory reaction with an increasing number of macrophages and lymphocytes and the formation of a fibroblast layer on the dura by day 7. Mean Liqoseal plus dura thickness reached a maximum of 1.2 mm (range 0.7– 2.0 mm) at day 7. Conclusion : The spinal dural histological reaction to Liqoseal during the first 7 days was similar to the cranial dural reaction. Liqoseal did not swell significantly in both application areas over time. Given the current lack of a safe and effective dural sealant for spinal ap-plication, we propose that an in- human safety study of Liqoseal is the logical next step.

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作者 Emma M.H.Slot [1] Wilhelmina Bergmann [2] Ahmet Kinaci [3] Bart de Boer [4] Nizar Moayeri [3] Saskia Redegeld [5] Sander van Thoor [5] Tristan P.C.van Doormaal [6] 学术成果认领
作者单位 Department of Neurology and Neurosurgery,University Medical Center Utrecht,Utrecht,the Netherlands;Department of Translational Neuroscience,Brain Center,University Medical Center Utrecht,Utrecht,the Netherlands [1] Department of Biomolecular Health Sciences,Division of Pathology,Faculty of Veterinary Medicine,Utrecht University,Utrecht,the Netherlands [2] Department of Neurology and Neurosurgery,University Medical Center Utrecht,Utrecht,the Netherlands [3] Department of Neurosurgery,Elizabeth TweeSteden ziekenhuis,Tilburg,the Netherlands [4] Brain Technology Institute,Utrecht,the Netherlands [5] Department of Neurology and Neurosurgery,University Medical Center Utrecht,Utrecht,the Netherlands;Department of Translational Neuroscience,Brain Center,University Medical Center Utrecht,Utrecht,the Netherlands;Department of Neurosurgery,Clinical Neuroscience Center,University Hospital Zurich,Zurich,Switzerland [6]
栏目名称 Regular Articles
DOI 10.1002/ame2.12294
发布时间 2023-03-16
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