The Efficacy and Safety of a Latest Dural Substitute

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-11-01

Brief Summary

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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 .

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Detailed Description

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Conditions

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Cerebrospinal Fluid Leak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DURAFORM

DURAFORM was used in repairing cerebral dura mater.

Group Type OTHER

DURAFORM

Intervention Type DEVICE

DURAFORM is a kind of conventional artificial Dura Mater

Lyoplant Onlay

Lyoplant Onlay was used in repairing cerebral dura mater.

Group Type EXPERIMENTAL

Lyoplant Onlay

Intervention Type DEVICE

Lyoplant Onlay is a kind of latest artificial Dura Mater

Interventions

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Lyoplant Onlay

Lyoplant Onlay is a kind of latest artificial Dura Mater

Intervention Type DEVICE

DURAFORM

DURAFORM is a kind of conventional artificial Dura Mater

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No