CompletedNot Applicable

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

Netherlands, Switzerland40 participantsStarted 2018-10-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of wound infection confirmed by increase of CRP and positive cultures

Timeframe: up to 30 days after surgery

Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)

Timeframe: intra-operative

Incidence of percutaneous CSF leak confirmed by β-2 transferrin test

Timeframe: up to 30 days after surgery

Trial details

NCT IDNCT03566602

SponsorPolyganics BV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More Cerebrospinal Fluid Leak trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of wound infection confirmed by increase of CRP and positive cultures

Timeframe: up to 30 days after surgery

Incidence of intra-operative CSF leakage after patch application at 15 cmH2O of Positive End Expiratory Pressure (PEEP)

Timeframe: intra-operative

Incidence of percutaneous CSF leak confirmed by β-2 transferrin test

Timeframe: up to 30 days after surgery