Study to Evaluate the Safety and Efficacy of Dural Repair Patch in Neurosurgical Repairs

NCT02129114 | Unknown

• 1 other identifier: MP-CT-RK2014
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.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 .
2. 2.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.
3. 3.To evaluate the safety and effectiveness of Dural Repair Patch in neurosurgical repairs of dural defects.

Conditions

Neurosurgical Repairs

Outcome Measures

Primary Outcomes (1)

• Rate of successful prevention of CSF leakage

  on Day 10±2 post operation, occurrence of CSF leakage is checked on both CT and clinical examination

  Day 10±2 post operation

Secondary Outcomes (1)

• Healing of scalp incision

  6 month

Study Arms (2)

ReDura Onlay

EXPERIMENTAL

The Dural Repair Patch manufactured by Guangzhou Medprin Regenerative Medical Technologies Co., Ltd.

Device: ReDura Onlay

DuraGen

ACTIVE COMPARATOR

Dural Graft Matrix manufactured by Integra LifeSciences (U.S.) Corporation.

Device: DuraGen

Interventions

ReDura Onlay DEVICE

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.

ReDura Onlay

DuraGen DEVICE

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.

DuraGen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female aged 18-65 years;
• whose expected survival is not less than 12 months
• Patients with dura mater defects which occurred in a variety of neurosurgeries (including traumatic brain injury, brain tumors, cerebrovascular disease, congenital neurological diseases, intra-spinal diseases and etc.) and required surgical repairing.
• All the enrolled subjects should not present obvious pre-operative inflammation symptoms,
• Written informed consents were obtained from all of the patients and/or their guardians.

You may not qualify if:

• Patient who present severe visceral (heart, liver, kidney, circulation system or etc.) diseases.
• Patient with unstable vital signs.
• Pregnant or lactating women.
• Patient who have a past history of serious allergy
• Patient who have a past history of severe immunodeficiency disease.
• Other undesirable conditions set by investigators.

Sponsors & Collaborators

• Medprin Regenerative Medical Technologies Co., Ltd.: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Study Officials

• Ke Yi Quan, professor

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Quan, Manager

CONTACT

020-32296115; tianquan@medprin.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

CN (1)