Safety and biodegradability of a synthetic dural sealant patch(Liqoseal)in a porcine cranial model

作     者：Ahmet Kinaci Wilhelmina Bergmann Sander van Thoor Saskia Redegeld Albert van der Zwan Tristan P.C.van Doormaal Ahmet Kinaci;Wilhelmina Bergmann;Sander van Thoor;Saskia Redegeld;Albert van der Zwan;Tristan P.C.van Doormaal

作者机构：Department of Neurology and NeurosurgeryBrain CenterUniversity Medical Centre UtrechtUtrechtThe Netherlands Brain Technology InstituteUtrechtThe Netherlands Division of PathologyFaculty of Veterinary MedicineUtrecht UniversityUtrechtThe Netherlands Department of NeurosurgeryClinical Neuroscience CenterUniversity Hospital ZurichZurichSwitzerland 

出 版 物：《Animal Models and Experimental Medicine》 (动物模型与实验医学（英文）)

年 卷 期：2021年第4卷第4期

页      面：398-405页

核心收录：

学科分类：0710[理学-生物学] 1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 10[医学] 

基　　金：Polyganics BV funded all experiments。 

主　　题：cerebrospinal fluid leakage craniotomy dura in vivo model sealant 

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 craniotomy 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 reaction 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.