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The Efficacy and Safety of a Latest Dural Substitute — ESLO  

Cerebrospinal Fluid Leak Clinical Trial

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

Clinical Trial 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 .

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04490629
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Jianmin Zhang, M.D.
Phone +86 0571 87784755
Email zjm135@zju.edu.cn
Status Recruiting
Phase N/A
Start date November 1, 2019
Completion date November 1, 2021
View Details
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