NCT04490629

The Efficacy and Safety of a Latest Dural Substitute

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Lyoplant Onlay	Lyoplant Onlay is a kind of latest artificial Dura Mater
DEVICE	DURAFORM	DURAFORM is a kind of conventional artificial Dura Mater

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2020-07-29
• Last updated: 2020-07-29

Locations

1 site across 1 country: China