Study to Evaluate the Safety and Efficacy of Dural Repair Patch in Neurosurgical Repairs
|ClinicalTrials.gov Identifier: NCT02129114|
Recruitment Status : Unknown
Verified July 2014 by Medprin Regenerative Medical Technologies Co., Ltd..
Recruitment status was: Recruiting
First Posted : May 2, 2014
Last Update Posted : July 8, 2014
- Most of dural defects may lead to subcutaneous effusion and Cerebral Spinal Fluid (CSF) leakage, which may result in infection; besides, direct adhesion of brain tissues with sub-scalp tissues also increase the risk of epilepsy, in severe cases, dural defect is considered a life-threatening condition. So, it's important to repair the dura mater for restoring its full integrity .
- Dural Repair Patch(ReDura Onlay) manufactured by Guangzhou Medprin Regenerative Medical Technologies Co., Ltd. As a product made of clinical absorbable polymer materials by using bionic technology, Dural Repair Patch has highly bionic 3-dimensional structure which is proved to facilitate migration and growth of regenerative cells, as well as to accelerate the growth and repairing of regenerative meninges. While the material is degraded gradually and absorbed by the body, regenerative meningeal tissue is gradually formed, achieving true reconstruction of the dura mater.
- To evaluate the safety and effectiveness of Dural Repair Patch in neurosurgical repairs of dural defects.
|Condition or disease||Intervention/treatment||Phase|
|Neurosurgical Repairs||Device: ReDura Onlay Device: DuraGen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multi-Center,Randomized,Non-Inferiority and Positively Controlled Clinical Trial to Evaluate the Safety and Efficacy of Dural Repair Patch in Neurosurgical Repairs|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||May 2015|
Experimental: ReDura Onlay
The Dural Repair Patch manufactured by Guangzhou Medprin Regenerative Medical Technologies Co., Ltd.
Device: ReDura Onlay
Subject will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of ReDura Onlay.
Active Comparator: DuraGen
Dural Graft Matrix manufactured by Integra LifeSciences (U.S.) Corporation.
Subject will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of DuraGen.
- Rate of successful prevention of CSF leakage [ Time Frame: Day 10±2 post operation ]on Day 10±2 post operation, occurrence of CSF leakage is checked on both CT and clinical examination
- Healing of scalp incision [ Time Frame: 6 month ]the healing of scalp incision is reviewed on Day 3, Day 5, Day7, Day 10, Month 3 and Month 6, respectively.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129114
|Contact: Tian Quan, Managerfirstname.lastname@example.org|
|Zhujiang Hospital of Southern Medical University||Recruiting|
|GuangZhou, Guangdong, China, 510000|
|Contact: Ke Yi Quan, Professor 020-61643266 email@example.com|
|Principal Investigator:||Ke Yi Quan, professor||Southern Medical University, China|