Comparing two dural sealants for preventing cerebrospinal fluid leaks after brain surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to collect post-approval data to compare the safety and effectiveness of CraniSeal Dural Sealant against DuraSeal Dural Sealant. It focuses on patients undergoing elective cranial surgery that involves a dural incision, assessing whether CraniSeal is non-inferior to DuraSeal in preventing post-operative cerebrospinal fluid leaks. The study will also evaluate additional safety outcomes, including surgical site infections and adverse events related to the devices used. Participants will be monitored for their recovery and any complications following the procedure.

Why it matters

Who can join: the full rules

General Inclusion Criteria:

1. Patient is ≥ 18 years of age
2. Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that entails a dural incision
3. Patient requires a procedure involving surgical wound classification Class I/Clean
4. Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures.
5. Patients who are able to comply with study requirements.

General Exclusion Criteria:

1. Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/ or any procedure that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded
2. Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
3. Patient with diagnosis of severely altered renal (creatinine levels \> 2.0 mg/dL) or hepatic (total bilirubin \> 2.5 mg/dL) function
4. Patient diagnosed with a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL)
5. Patients undergoing cranial procedures involving petrous bone drilling
6. Patients with traumatic injuries to the head or dural disease in planned dural closure area
7. Patients who are pregnant or lactating
8. Patient with an active infection
9. Patient is undergoing cranial procedures involving non-autologous duraplasty material that are not collagen based
10. Patients requiring re-opening of planned surgical area within 90 days after surgery.
11. Patient with a known allergy to FD\&C Blue #1 dye
12. Patient is not able to tolerate multiple Valsalva maneuvers, or transient elevation of CSF pressure during Valsalva maneuvers is not possible (e.g. the presence of a temporary or permanent CSF shunt
13. Presence of hydrocephalus
14. Patient with a diagnosis of uncontrolled diabetes (e.g., persistent HbA1c elevation of \>9% despite standard diabetes care),
15. Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT\>37 seconds or INR \>1.5 units)
16. Patient is not likely to comply with the follow-up evaluation schedule.
17. Contraindications to both an MRI and CT scan.
18. Patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy. (Observational studies on FDA approved products are not applicable)
19. Patients diagnosed with Meningiomatosis (multiple meningiomas)

Where it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Augusta University
  Augusta, Georgia, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Jacobs Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Study coordinator: M Pace
• Email: mike.pace@pramandllc.com
• Phone: 6172335873

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TachoSil vs DuraSeal for Supporting Dural Sealing in Adults

  This retrospective study looks at whether TachoSil works as well as DuraSeal to prevent CSF leaks or pseudomeningoceles after cranial or spinal surgeries in adults.

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• Cerebrospinal fluid leak after brain tumor surgery

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• Sealant versus no sealant to prevent CSF leaks after endoscopic endonasal skull base surgery

  We will try fibrin or synthetic sealants versus no sealant to see if they prevent postoperative CSF leaks in adults having endoscopic endonasal skull base surgery who are judged to be at low risk for leaks.

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• Registry for spontaneous intracranial hypotension and post-dural puncture headache

  This study is collecting information from people with spinal fluid leaks to better understand the causes and symptoms of headaches related to spontaneous intracranial hypotension and post-dural puncture headache.

  Recruiting University Hospital Freiburg · Freiburg im Breisgau · NCT06711731

• Dural Sealant Used After Neurosurgery to Help Ensure Watertight Closure

  This registry follows adults who receive Immiseal after neurosurgical dural repair to see how safe and effective it is in real-world use.

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• Understanding post‑cardiac arrest brain injury through spinal fluid molecular analysis

  This project will test whether detailed molecular analysis of spinal fluid from people who had a cardiac arrest can reveal targets for new treatments.

  Recruiting Chungnam National University Hospital · Daejeon, Jung-gu · NCT07481396

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.