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

A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sally Jin

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2018

Primary Completion (Anticipated)

August 30, 2019

Study Completion (Anticipated)

August 30, 2019

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • AAG-G-H-1715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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