Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

Inclusion criteria

pre-operative

• Subjects who are able to provide written informed consent prior to participating in the clinical investigation.
• Subjects who are ≥ 18 years old.
• Subjects who are able to comply with the follow-up or other study requirements.
• Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed.
• Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery.

intra-operative

• Subjects with surgical wound classification Class I/Clean.
• Subjects with minimally 5 mm of dural space surrounding dural opening.

Exclusion criteria

pre-operative

• Female subjects who are pregnant or breastfeeding.
• Subjects with an assumed impaired coagulation due to medication or otherwise.
• Subjects suspected of an infection requiring antibiotics.
• Subjects with any type of dural diseases in planned dural closure area.
• Subjects requiring re-opening of planned surgical area within 90 days after surgery.
• Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®.
• Subjects who previously received a LIQOSEAL®.
• Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening.
• Subjects with a presence of hydrocephalus.
• Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g. knee replacement].

intra-operative

• Subjects in whom elevation of PEEP has a potential detrimental effect.
• Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
• Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.
• Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.
• Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm.
• Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).