Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
224 participants
INTERVENTIONAL
2024-05-29
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CraniSeal
CraniSeal
CraniSeal
CraniSeal is a PEG Dural Sealant
DuraSeal
DuraSeal
DuraSeal
DuraSeal is a PEG Dural Sealant
Interventions
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CraniSeal
CraniSeal is a PEG Dural Sealant
DuraSeal
DuraSeal is a PEG Dural Sealant
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Pramand LLC
INDUSTRY
Responsible Party
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Locations
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Keck Medical Center at USC
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Jacobs Institute
Buffalo, New York, United States
Prisma Health
Greenville, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Other Identifiers
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PRA-CT-0003
Identifier Type: -
Identifier Source: org_study_id