Single-arm, open-label, multicenter study to evaluate the safety and performance of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery
- Conditions
- brain fluidCSF leakage10009720
- Registration Number
- NL-OMON48601
- Lead Sponsor
- Polyganics BV, Groningen
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
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 followup 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.
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. Subjects with contra-indication to MRI. Intraoperative; Subjects in whom elevation of PEEP or pCO2 has a potential detrimental effect. Subjects who will require a CSF or wound drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery. Primary closure of the dura mater with synthetic, non-autologous or autologous material other than galea. A gap > 3 mm after primary closure of the dura mater.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a combined endpoint of any neurosurgical events defined<br /><br>as:<br /><br>Safety<br /><br>1. Incidence of wound infection confirmed by increase of CRP and positive<br /><br>cultures up to 30 days after surgery;<br /><br>Performance<br /><br>2. Incidence of intra-operative CSF leakage after patch application at 20 cmH2O<br /><br>of Positive End Expiratory Pressure (PEEP);<br /><br>3. Incidence of percutaneous CSF leak confirmed by *-2 transferrin test up to<br /><br>30 days after surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety<br /><br>* Incidence of device related AEs throughout the study up to 90 days after<br /><br>surgery<br /><br>* Incidence of device related AEs throughout the study up to 360 days after<br /><br>surgery<br /><br>* Incidence of wound infection confirmed by increase of CRP and positive<br /><br>cultures up to 90 days after surgery<br /><br>Performance<br /><br>* Incidence of percutaneous CSF leak confirmed by *-2 transferrin test up to 90<br /><br>days after surgery<br /><br>* Incidence of pseudomeningocele with the need of puncture, external lumbar<br /><br>drainage or surgical evacuation as assessed by treating physician up to 90 days<br /><br>after surgery<br /><br>* Incidence of pseudomeningocele >20 cc as confirmed on MRI<br /><br>* Thickness of dura mater and Dura Sealant Patch (combined) in mm analyzed with<br /><br>MRI</p><br>