NCT03566602
Completed
Not Applicable
Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Polyganics BV3 sites in 2 countries40 target enrollmentStarted: October 11, 2018Last updated:
ConditionsCerebrospinal Fluid Leak
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Polyganics BV
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Incidence of percutaneous CSF leak confirmed by β-2 transferrin test
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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. 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.
Outcomes
Primary Outcomes
Incidence of percutaneous CSF leak confirmed by β-2 transferrin test
Time Frame: up to 30 days after surgery
Percutaneous CSF leak confirmed by β-2 transferrin test
Incidence of wound infection confirmed by increase of CRP and positive cultures
Time Frame: up to 30 days after surgery
wound infection confirmed by increase of CRP and positive cultures
Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)
Time Frame: intra-operative
intra-operative CSF leakage
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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