Abstract
Cerebrospinal fluid leakage is a frequent complication after cranial and spinal surgery. To prevent this complication and seal the dura watertight, we developed Liqoseal, a dural sealant patch comprising a watertight polyesterurethane layer and an adhesive layer consisting of poly(DL-lactide-co-ε-caprolactone) copolymer and multiarmed N-hydroxylsuccinimide functionalized polyethylene glycol. We compared acute burst pressure and resistance to physiological conditions for 72 h of Liqoseal, Adherus, Duraseal, Tachosil, and Tisseel using computer-assisted models and fresh porcine dura. The mean acute burst pressure of Liqoseal in the cranial model (145 ± 39 mmHg) was higher than that of Adherus (87 ± 47 mmHg), Duraseal (51 ± 42 mmHg) and Tachosil (71 ± 16 mmHg). Under physiological conditions, cranial model resistance test results showed that 2 of 3 Liqoseal sealants maintained dural attachment during 72 hours as opposed to 3 of 3 for Adherus and Duraseal and 0 of 3 for Tachosil. The mean burst pressure of Liqoseal in the spinal model (233 ± 81 mmHg) was higher than that of Tachosil (123 ± 63 mmHg) and Tisseel (23 ± 16 mmHg). Under physiological conditions, spinal model resistance test results showed that 2 of 3 Liqoseal sealants maintained dural attachment for 72 hours as opposed to 3 of 3 for Adherus and 0 of 3 for Duraseal and Tachosil. This novel study showed that Liqoseal is capable of achieving a strong watertight seal over a dural defect in ex vivo models.
Highlights
Cerebrospinal fluid (CSF) leakage is a potentially severe complication in neurosurgery that occurs in 8.2–13.8% of all cases following intradural surgery or because of an unintended durotomy in extradural spinal surgery [1, 2]
Watertight closure of the dura is considered a cornerstone of treatment to prevent CSF leakage
Recent systematic reviews have shown that clinically used sealants do not reduce the rate of CSF leakage after cranial and spinal surgery [1, 2]
Summary
Cerebrospinal fluid (CSF) leakage is a potentially severe complication in neurosurgery that occurs in 8.2–13.8% of all cases following intradural surgery or because of an unintended durotomy in extradural spinal surgery [1, 2].Persistent leakage of CSF can lead to secondary complications, such as postural headache, durocutaneous fistula, impaired wound healing, wound infection, meningitis, and intracranial hemorrhage [3,4,5,6]. Watertight closure of the dura is considered a cornerstone of treatment to prevent CSF leakage. An ex vivo model was designed to test the effectiveness of the most clinically used sealants in an objective and standardized manner [10]. This model showed that most of the current sealants failed to resist physiological intracranial pressure (16 mmHg) or that the sealants detached from the dura under chronic physiological conditions. There is a need for an effective dural sealant to prevent CSF leakage. A new multilayered dural sealant patch named Liqoseal (Polyganics B.V., Groningen, The Netherlands), has been developed for watertight closure of the dura. The sealant consists of two layers, namely, a watertight layer comprising biodegradable polyesterurethane (PU) and an adhesive layer comprising biodegradable poly (DL-lactide-co-ε-caprolactone) copolymer (DL-PLCL) and multiarmed N-hydroxylsuccinimide (NHS) functionalized polyethylene glycol (PEG-NHS) (Fig. 1)
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