The Efficacy and Safety of a Latest Dural Substitute

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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Updated on 19 February 2024
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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 regarded as the control group. a total of 80 patients were randomized into experimental and control group (1:1).Data were collected on complications resulting in CSF leaks, surgical site infections, instrument performance parameterized other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times. The above-mentioned date were used to evaluate the efficacy and safety of Lyoplant Onlay .

Details
Condition Cerebrospinal Fluid Leak
Age 18years - 75years
Treatment Lyoplant Onlay, DURAFORM
Clinical Study IdentifierNCT04490629
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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