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

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

doi:10.1002/ame2.12184

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

Ahmet Kinaci, Wilhelmina Bergmann, Sander van Thoor, Saskia Redegeld, Albert van der Zwan, Tristan P C van Doormaal

Research output: Contribution to journal › Article › Academic › peer-review

4 Downloads (Pure)

Abstract

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.

Original language	English
Pages (from-to)	398-405
Number of pages	8
Journal	Animal models and experimental medicine
Volume	4
Issue number	4
DOIs	https://doi.org/10.1002/ame2.12184
Publication status	Published - Dec 2021

Keywords

cerebrospinal fluid leakage
craniotomy
dura
in vivo model
sealant

Access to Document

10.1002/ame2.12184Licence: CC BY-NC-ND

Anim Models and Exp Med - 2021 - Kinaci - Safety and biodegradability of a synthetic dural sealant patch Liqoseal in aFinal published version, 2.16 MBLicence: CC BY-NC-ND

Cite this

@article{d4e3999f5d3343f2a2858d0ffe1ca164,

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

abstract = "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.",

keywords = "cerebrospinal fluid leakage, craniotomy, dura, in vivo model, sealant",

author = "Ahmet Kinaci and Wilhelmina Bergmann and \{van Thoor\}, Sander and Saskia Redegeld and \{van der Zwan\}, Albert and \{van Doormaal\}, \{Tristan P C\}",

note = "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: {\textcopyright} 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.",

year = "2021",

month = dec,

doi = "10.1002/ame2.12184",

language = "English",

volume = "4",

pages = "398--405",

journal = "Animal models and experimental medicine",

issn = "2096-5451",

publisher = "John Wiley \& Sons Inc.",

number = "4",

}

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 - https://www.scopus.com/pages/publications/85129034947

U2 - 10.1002/ame2.12184

DO - 10.1002/ame2.12184

M3 - Article

C2 - 34977491

SN - 2096-5451

VL - 4

SP - 398

EP - 405

JO - Animal models and experimental medicine

JF - Animal models and experimental medicine

IS - 4

ER -

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

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this