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

Zhejiang University

Status: Unknown

Conditions: Cerebrospinal Fluid Leak

Treatments: Device: DURAFORM; Device: Lyoplant Onlay

Study type: Interventional

Funder types: Other

Identifiers

NCT04490629

2017-126

Details and patient eligibility

About

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 .

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

DURAFORM

Other group

Description:

DURAFORM was used in repairing cerebral dura mater.

Treatment:

Device: DURAFORM

Lyoplant Onlay

Experimental group

Description:

Lyoplant Onlay was used in repairing cerebral dura mater.

Treatment:

Device: Lyoplant Onlay