The Efficacy and Safety of a Latest Dural Substitute

NCT04490629 | Unknown

• 1 other identifier: 2017-126
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 .

Conditions

Cerebrospinal Fluid Leak

Keywords

Dura Mater; Cerebrospinal Fluid Leak

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• neurosurgical complication

  2 days post surgery/10 days post surgery/at 30 days post surgery

Study Arms (2)

DURAFORM

OTHER

DURAFORM was used in repairing cerebral dura mater.

Device: DURAFORM

Lyoplant Onlay

EXPERIMENTAL

Lyoplant Onlay was used in repairing cerebral dura mater.

Device: Lyoplant Onlay

Interventions

Lyoplant Onlay DEVICE

Lyoplant Onlay is a kind of latest artificial Dura Mater

Lyoplant Onlay

DURAFORM DEVICE

DURAFORM is a kind of conventional artificial Dura Mater

DURAFORM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Jianmin Zhang

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• jianmin zhang, M.D.

  Department of neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianmin Zhang, M.D.

CONTACT

+86 0571 87784755; zjm135@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 29, 2020
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)