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

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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
Sponsor:
Information provided by (Responsible Party):
Medprin Regenerative Medical Technologies Co., Ltd.

Brief Summary:
  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. 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. 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: DuraGen
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. male or female aged 18-65 years;
  2. whose expected survival is not less than 12 months
  3. 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.
  4. All the enrolled subjects should not present obvious pre-operative inflammation symptoms,
  5. Written informed consents were obtained from all of the patients and/or their guardians.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129114


Contacts
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Contact: Tian Quan, Manager 020-32296115 tianquan@medprin.com

Locations
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China, Guangdong
Zhujiang Hospital of Southern Medical University Recruiting
GuangZhou, Guangdong, China, 510000
Contact: Ke Yi Quan, Professor    020-61643266    net_chn@hotmail.com   
Sponsors and Collaborators
Medprin Regenerative Medical Technologies Co., Ltd.
Investigators
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Principal Investigator: Ke Yi Quan, professor Southern Medical University, China

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Responsible Party: Medprin Regenerative Medical Technologies Co., Ltd.
ClinicalTrials.gov Identifier: NCT02129114     History of Changes
Other Study ID Numbers: MP-CT-RK2014
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female