The Efficacy and Safety of a Latest Dural Substitute

Cerebrospinal Fluid Leak Clinical Trial

— ESLO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490629
• Other study ID #: 2017-126
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: July 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jianmin Zhang, M.D.
• Phone: +86 0571 87784755
• Email: zjm135[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak

Intervention

Device:
• Lyoplant Onlay
Lyoplant Onlay is a kind of latest artificial Dura Mater
• DURAFORM
DURAFORM is a kind of conventional artificial Dura Mater

Locations

Country	Name	City	State
China	Jianmin Zhang	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical successful rate	proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.	at 30 days post surgery
Secondary	neurosurgical complication	Incidence of intracranial infection at 2 days after operation,at discharge,and at 30 days after operation	2 days post surgery/10 days post surgery/at 30 days post surgery