The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Preoperative Subjects who are able to provide a 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 who are planned for an elective intracranial intradural surgery in whom a dural incision of at least 2 cm in length is necessary, which will be closed.
Female subjects of child bearing potential must agree to use any form of contraception from the time of signing the informed consent form through 90 days post-surgery.
Intraoperative Surgical wound classification Class I/Clean. Minimally 5 mm of dural space surrounding dural opening.
Exclusion Criteria:
Preoperative 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 requiring local radiotherapy in planned surgical area. Subjects with a known allergy to any of the components of the Dura Sealant Patch.
Subject who previously participated in this study or any investigational drug or device study within 30 days of screening.
Subjects with a presence of hydrocephalus. Intraoperative Subjects in whom elevation of PEEP or pCO2 has a potential detrimental effect. Su…
What they're measuring
1
Incidence of wound infection confirmed by increase of CRP and positive cultures
Timeframe: up to 30 days after surgery
2
Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)
Timeframe: intra-operative
3
Incidence of percutaneous CSF leak confirmed by β-2 transferrin test