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Prospective, randomized, parallel controlled, single blind, non inferior, multicenter clinical trial of biological patch for surgical repair of dural defects

Prospective, randomized, parallel controlled, single blind, non inferior, multicenter clinical trial of biological patch for surgical repair of dural defects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063654
Enrollment
Unknown
Registered
2022-09-14
Start date
2022-08-31
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dural defect

Interventions

Test Grooup:Dural patch
Control Group:Biological dura mater patch

Sponsors

Sanbo Brain Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects participating in this clinical trial must meet all the following criteria: 1) Age 18-75 (including the threshold), regardless of gender; 2) Those who plan to repair dura mater defects due to various reasons (such as brain and spinal cord injuries, tumors, and other brain diseases);

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following exclusion criteria shall not be included in the trial: 1) those with unstable vital signs and bilateral mydriasis in the late stage of cerebral hernia; 2) Patients with preoperative cardiac arrest due to craniocerebral trauma, or patients with severe organic diseases who cannot tolerate craniocerebral surgery; 3) Patients with infection or inflammation in the operation area, and patients with serious skin diseases in the operation area;

Design outcomes

Primary

MeasureTime frame
Success rate of dural repair;

Countries

China

Contacts

Public ContactYan Changxiang
yancx65828@163.com010-62856916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026