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

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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

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

Trial contacts and locations

0

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Central trial contact

Jianmin Zhang, M.D.

Data sourced from clinicaltrials.gov

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