The Efficacy and Safety of a Latest Dural Substitute

Not Applicable

• Conditions: Cerebrospinal Fluid Leak
• Interventions: Device: Lyoplant Onlay; Device: DURAFORM

• Registration Number: NCT04490629
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-26
• Last Update Submitted: 2020-07-26
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29
• Primary Completion: 2020-11-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lyoplant Onlay	Lyoplant Onlay	Lyoplant Onlay was used in repairing cerebral dura mater.
DURAFORM	DURAFORM	DURAFORM was used in repairing cerebral dura mater.

Primary Outcome Measures

Name	Time	Method
surgical successful rate	at 30 days post surgery	proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.

Secondary Outcome Measures

Name	Time	Method
neurosurgical complication	2 days post surgery/10 days post surgery/at 30 days post surgery	Incidence of intracranial infection at 2 days after operation，at discharge，and at 30 days after operation

Trial Locations

Locations (1)

Jianmin Zhang; 🇨🇳 Hangzhou, Zhejiang, China