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出境医 / 临床实验 / The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater

The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater

Study Description
Brief Summary:
Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.

Condition or disease Intervention/treatment Phase
Replacement and Extension of Connective Tissue Structure in Neurosurgery Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Lyoplant® Onlay
All the model including 2.5cm×2.5cm, 5.0cm×5.0cm,2.5cm×7.5cm,7.5cm×7.5cm,10.0cm×12.5cm will be used in this study
Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed.

Active Comparator: DURAFORM™ Dural Graft Implant
All the model including 2.54cm×2.54cm,5.08cm×5.08cm, 2.54cm×7.62cm, 7.62cm×7.62cm,10.16cm×12.70cm will be used in this study
Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed.

Outcome Measures
Primary Outcome Measures :
  1. Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days [ Time Frame: 90days ]
    Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days after the surgery (Confirmed by radiological image evaluation and physical examination on surgical site). Each patient firstly undergoes an initial CT and if necessary, MRI will be used to further examine the volume of CSF leakage.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Surgical patients who will receive dura mater replacement in neurosurgery;
  2. 18 to 75 years old, either sexes;
  3. Patients are ready and able to accept all visits during the trial.
  4. Patients are willing and able to sign Informed Consent Form (ICF) to join this clinical trial.

Related to lesions:

  1. Target lesion is cerebral and cerebellum dura mater defect closure, intracranial hypertension remission;
  2. Surgical wound classification is Class I/sterile operation and risk index category (RIC) ≤ 2.

Exclusion Criteria:

  1. Patients with local cerebral infection;
  2. Patients who suffer from systemic infection (e.g. urinary tract infection (UTI), acquired pneumonia) or any infection sign at surgical site before the surgery, with body temperature > 38.5℃, positive result in blood culture, and/or positive result in chest X-ray examination;
  3. Patients who are allergic to the equipment components (Such as, by asking the patient's history of allergies, doctors understand whether the patient is allergic to proteins of bovine origin or implant or not);
  4. There is metal implant in patient's brain and the implant will interfere the assessment on devices or surgery recovery;
  5. Patients in gestation period or lactation period or planned to be pregnant during the trial;
  6. Patients with more than 1 separated dura mater defects;
  7. Patients with previous neurosurgery history at the same anatomic site;
  8. Patients with cranial open trauma;
  9. Patients requiring the use of dura adhesive or sealant;
  10. Patients whose expected survival time is less than 12 months;
  11. Patients received chemotherapy and/or radiotherapy within 3 months before the surgery;
  12. Patients who had diagnosed as malignant tumor of other parts except brain tumor, uncontrolled diabetes, septicemia, systemic collagen diseases clinically;
  13. Patients who had been accompanied with liver and renal dysfunction, with ALT and AST>1.5 times the upper limit of the standard, total bilirubin level > 2.5 mg/dl, creatinine level > 2.0 mg/dl;
  14. Patients with significant clinical coagulation disorders, Activated partial thromboplastin time (APTT) was 3 times more than ULN (upper limit of normal), international normalized ratio (INR) is ≥ 1.7, or under the treatment of Warfarin or Coumadin;
  15. Patients with immune system damage or autoimmune diseases (white blood cell (WBC) count is < 4000/uL or >20,000/uL);
  16. Patients whose serological test results show that people with hepatitis B, hepatitis C, syphilis, AIDS and other infectious diseases during screening period;
  17. Patients in whom subdural drainage for more than 2 days must be performed in the surgery;
  18. Patients who are participating other clinical trials of investigational devices/drugs;
  19. Patients who are not suitable for this study as determined by the investigators.
Contacts and Locations

Contacts
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Contact: Zongjie Duan +86 10 57632775 zongjie.duan@bbraun.com
Contact: Sally Jin

Locations
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China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Jianmin Zhang    86 571 87784715    z2sjwk@sina.com   
Sponsors and Collaborators
B. Braun Medical International Trading Company Ltd.
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE July 24, 2018
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days [ Time Frame: 90days ]
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days after the surgery (Confirmed by radiological image evaluation and physical examination on surgical site). Each patient firstly undergoes an initial CT and if necessary, MRI will be used to further examine the volume of CSF leakage.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater
Official Title  ICMJE A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater
Brief Summary Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Replacement and Extension of Connective Tissue Structure in Neurosurgery
Intervention  ICMJE Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed.
Study Arms  ICMJE
  • Experimental: Lyoplant® Onlay
    All the model including 2.5cm×2.5cm, 5.0cm×5.0cm,2.5cm×7.5cm,7.5cm×7.5cm,10.0cm×12.5cm will be used in this study
    Intervention: Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
  • Active Comparator: DURAFORM™ Dural Graft Implant
    All the model including 2.54cm×2.54cm,5.08cm×5.08cm, 2.54cm×7.62cm, 7.62cm×7.62cm,10.16cm×12.70cm will be used in this study
    Intervention: Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2019
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Surgical patients who will receive dura mater replacement in neurosurgery;
  2. 18 to 75 years old, either sexes;
  3. Patients are ready and able to accept all visits during the trial.
  4. Patients are willing and able to sign Informed Consent Form (ICF) to join this clinical trial.

Related to lesions:

  1. Target lesion is cerebral and cerebellum dura mater defect closure, intracranial hypertension remission;
  2. Surgical wound classification is Class I/sterile operation and risk index category (RIC) ≤ 2.

Exclusion Criteria:

  1. Patients with local cerebral infection;
  2. Patients who suffer from systemic infection (e.g. urinary tract infection (UTI), acquired pneumonia) or any infection sign at surgical site before the surgery, with body temperature > 38.5℃, positive result in blood culture, and/or positive result in chest X-ray examination;
  3. Patients who are allergic to the equipment components (Such as, by asking the patient's history of allergies, doctors understand whether the patient is allergic to proteins of bovine origin or implant or not);
  4. There is metal implant in patient's brain and the implant will interfere the assessment on devices or surgery recovery;
  5. Patients in gestation period or lactation period or planned to be pregnant during the trial;
  6. Patients with more than 1 separated dura mater defects;
  7. Patients with previous neurosurgery history at the same anatomic site;
  8. Patients with cranial open trauma;
  9. Patients requiring the use of dura adhesive or sealant;
  10. Patients whose expected survival time is less than 12 months;
  11. Patients received chemotherapy and/or radiotherapy within 3 months before the surgery;
  12. Patients who had diagnosed as malignant tumor of other parts except brain tumor, uncontrolled diabetes, septicemia, systemic collagen diseases clinically;
  13. Patients who had been accompanied with liver and renal dysfunction, with ALT and AST>1.5 times the upper limit of the standard, total bilirubin level > 2.5 mg/dl, creatinine level > 2.0 mg/dl;
  14. Patients with significant clinical coagulation disorders, Activated partial thromboplastin time (APTT) was 3 times more than ULN (upper limit of normal), international normalized ratio (INR) is ≥ 1.7, or under the treatment of Warfarin or Coumadin;
  15. Patients with immune system damage or autoimmune diseases (white blood cell (WBC) count is < 4000/uL or >20,000/uL);
  16. Patients whose serological test results show that people with hepatitis B, hepatitis C, syphilis, AIDS and other infectious diseases during screening period;
  17. Patients in whom subdural drainage for more than 2 days must be performed in the surgery;
  18. Patients who are participating other clinical trials of investigational devices/drugs;
  19. Patients who are not suitable for this study as determined by the investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951272
Other Study ID Numbers  ICMJE AAG-G-H-1715
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party B. Braun Medical International Trading Company Ltd.
Study Sponsor  ICMJE B. Braun Medical International Trading Company Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account B. Braun Medical International Trading Company Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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