Status:
UNKNOWN
The Efficacy and Safety of a Latest Dural Substitute
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Cerebrospinal Fluid Leak
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarde...
Eligibility Criteria
Inclusion
- Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision.
- Dural defects and surgical incision was classifed as level 1
Exclusion
- local or systemic infection.
- patients with known allergy to Equipment components
- a history of traumatic head injury
- a compromised immune system or autoimmune disease
- patients who should not participate based on the surgeon's opinion
- patients participating in any other drug or device trial.
- expected survival time \<12 months
- underwent chemoradiotherapy 3 months before randomization
- uncontrolled diabetes and malignant tumor
- women who were pregnant, lactating, or wished to become pregnant during the study;
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04490629
Start Date
November 1 2019
End Date
November 1 2021
Last Update
July 29 2020
Active Locations (1)
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1
Jianmin Zhang
Hangzhou, Zhejiang, China, 310000