TY - JOUR
T1 - Safety and biodegradability of a synthetic dural sealant patch (Liqoseal) in a porcine cranial model
AU - Kinaci, Ahmet
AU - Bergmann, Wilhelmina
AU - van Thoor, Sander
AU - Redegeld, Saskia
AU - van der Zwan, Albert
AU - van Doormaal, Tristan P C
N1 - Funding Information:
T.P.C. van Doormaal, MD PhD is consultant for Polyganics B.V. A. Kinaci's PhD position was funded by Polyganics B.V.
Publisher Copyright:
© 2021 The Authors. Animal Models and Experimental Medicine published by John Wiley & Sons Australia, Ltd on behalf of The Chinese Association for Laboratory Animal Sciences.
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - cerebrospinal fluid leakage
KW - craniotomy
KW - dura
KW - in vivo model
KW - sealant
UR - http://www.scopus.com/inward/record.url?scp=85129034947&partnerID=8YFLogxK
U2 - 10.1002/ame2.12184
DO - 10.1002/ame2.12184
M3 - Article
C2 - 34977491
SN - 2576-2095
VL - 4
SP - 398
EP - 405
JO - Animal models and experimental medicine
JF - Animal models and experimental medicine
IS - 4
ER -