The Efficacy and Safety of a Latest Dural Substitute

Brief Title

The Efficacy and Safety of a Latest Dural Substitute

Official Title

A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater

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 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 .
    



Study Type

Interventional


Primary Outcome

surgical successful rate

Secondary Outcome

 neurosurgical complication

Condition

Cerebrospinal Fluid Leak

Intervention

Lyoplant Onlay

Study Arms / Comparison Groups

 DURAFORM
Description:  DURAFORM was used in repairing cerebral dura mater.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

80

Start Date

November 1, 2019

Completion Date

November 1, 2021

Primary Completion Date

November 1, 2020

Eligibility Criteria

        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;
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

jianmin zhang, M.D., +86 0571 87784755, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04490629

Organization ID

2017-126


Responsible Party

Sponsor

Study Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University


Study Sponsor

jianmin zhang, M.D., Principal Investigator, Department of neurosurgery


Verification Date

July 2020