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 

机构地区：[1]Department of Neurology and Neurosurgery,Brain Center,University Medical Centre Utrecht,Utrecht,The Netherlands [2]Brain Technology Institute,Utrecht,The Netherlands [3]Division of Pathology,Faculty of Veterinary Medicine,Utrecht University,Utrecht,The Netherlands [4]Department of Neurosurgery,Clinical Neuroscience Center,University Hospital Zurich,Zurich,Switzerland

出　　处：《Animal Models and Experimental Medicine》2021年第4期398-405,共8页动物模型与实验医学（英文）

基　　金：Polyganics BV funded all experiments。

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.

关 键 词：cerebrospinal fluid leakage CRANIOTOMY DURA in vivo model SEALANT 

分 类 号：R651.1[医药卫生—外科学] R-332[医药卫生—临床医学]