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

• Published in: Animal models and experimental medicine Vol. 4; no. 4; pp. 398 - 405
• Main Authors: Kinaci, Ahmet, Bergmann, Wilhelmina, Thoor, Sander, Redegeld, Saskia, Zwan, Albert, Doormaal, Tristan P. C.
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.12.2021; John Wiley and Sons Inc; Wiley
• Subjects: Animals; Arachnoid; Biodegradability; Cerebrospinal fluid; Cerebrospinal Fluid Leak - prevention & control; cerebrospinal fluid leakage; Clinical trials; Craniotomy; dura; Dura Mater - surgery; Foreign bodies; Hogs; in vivo model; Laboratory animals; Magnetic resonance imaging; Original; Physiology; Polyethylene glycol; Polyethylene Glycols - adverse effects; Regular; Safety; sealant; Sealing compounds; Skull - surgery; Surgery; Sutures; Swine; Wound healing; United States > US; in vivo model; sealant; craniotomy; cerebrospinal fluid leakage; dura
• ISSN: 2576-2095; 2096-5451; 2576-2095
• DOI: 10.1002/ame2.12184

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.