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

A Multicenter, Single-Blind, Prospective Randomized Post-Approval Study Comparing the Safety and Effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant for Dural Sealing in Elective Cranial Surgery

This study is testing whether a new sealant called CraniSeal is as good as the existing DuraSeal at preventing leaks of spinal fluid after brain surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pramand LLC (Industry-sponsored)
• Locations: 8 sites (Los Angeles, California and 7 other locations)
• Trial ID: NCT06406790 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for elective cranial procedures involving a dural incision.

Not a fit: Patients requiring procedures that penetrate air sinuses or have had prior neurosurgery in the same area may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective option for preventing cerebrospinal fluid leaks in patients undergoing cranial surgery.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating dural sealants, indicating a promising avenue for further investigation.

Eligibility criteria

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 this trial is running

Los Angeles, California and 7 other locations

• Keck Medical Center at USC — Los Angeles, California, United States (Completed)
• 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)
• Prisma Health — Greenville, South Carolina, United States (Recruiting)

Study contacts

• Study coordinator: M Pace

Conditions Leak, Cerebrospinal Fluid