The Efficacy and Safety of a Latest Dural Substitute (ESLO)

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

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 Overview

• Status: Unknown
• Conditions: Cerebrospinal Fluid Leak
• Intervention / Treatment: Device: DURAFORM; Device: Lyoplant Onlay

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Jianmin Zhang
      • Principal Investigator: Junming Zhu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DURAFORM; DURAFORM was used in repairing cerebral dura mater.	Device: DURAFORM; DURAFORM is a kind of conventional artificial Dura Mater
Experimental: Lyoplant Onlay; Lyoplant Onlay was used in repairing cerebral dura mater.	Device: Lyoplant Onlay; Lyoplant Onlay is a kind of latest artificial Dura Mater

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cerebrospinal Fluid Leak; Dura Mater
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cerebrospinal Fluid Leak
• Other Study ID Numbers: 2017-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The committee will debate whether to share IPD depending on the circumstances. Because some patients are unwilling to make their condition known.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No