DOI: 10.1002/ame2.12184
Safety and biodegradability of a synthetic dural sealant patch (Liqoseal) in a porcine cranial model
Ahmet Kinaci1
Wilhelmina Bergmann2
Sander van Thoor3
Saskia Redegeld3
Albert van der Zwan1
Tristan P.C.van Doormaal4
1.Department of Neurology and Neurosurgery,Brain Center,University Medical Centre Utrecht,Utrecht,The Netherlands;Brain Technology Institute,Utrecht,The Netherlands2.Division of Pathology,Faculty of Veterinary Medicine,Utrecht University,Utrecht,The Netherlands3.Brain Technology Institute,Utrecht,The Netherlands4.Department of Neurology and Neurosurgery,Brain Center,University Medical Centre Utrecht,Utrecht,The Netherlands;Brain Technology Institute,Utrecht,The Netherlands;Department of Neurosurgery,Clinical Neuroscience Center,University Hospital Zurich,Zurich,Switzerland
摘要：Background : Liqoseal consists of a watertight layer of poly(ester)ether urethane and an adhesive layer containing polyethylene glycol- N - hydroxysuccinimide (PEG- NHS). It is designed to prevent cerebrospinal fluid (CSF) leakage after intradural surgery. This study assessed the safety and biodegradability of Liqoseal in a porcine crani-otomy model.Methods : In 32 pigs a craniotomy plus durotomy was performed. In 15 pigs Liqoseal was implanted, in 11 control pigs no sealant was implanted and in 6 control pigs a control dural sealant (Duraseal or Tachosil) was implanted. The safety of Liqoseal was evaluated by clinical, MRI and histological assessment. The degradation of Liqoseal was histologically estimated. Results : Liqoseal, 2 mm thick before application, did not swell and significantly was at maximum mean thickness of 2.14 (±0.37) mm at one month. The foreign body reac-tion induced by Liqoseal, Duraseal and Tachosil were comparable. Liqoseal showed no adherence to the arachnoid layer and was completely resorbed between 6 and 12 months postoperatively. In one animal with Liqoseal, an epidural fluid collection containing CSF could not be excluded. Conclusion : Liqoseal seems to be safe for intracranial use and is biodegradable. The safety and performance in humans needs to be further assessed in clinical trials.
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论文发表日期：2021-12-25
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：8( 398-405 )
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