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A Prospective Randomized Controlled Study Evaluating the Safety and Efficacy of EVICEL used for Suture-Line Sealing in Dura-Mater Closure during Paediatric Neurosurgical Cranial Procedures

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Trial Profile

A Prospective Randomized Controlled Study Evaluating the Safety and Efficacy of EVICEL used for Suture-Line Sealing in Dura-Mater Closure during Paediatric Neurosurgical Cranial Procedures

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 16 Jul 2023

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At a glance

  • Drugs Fibrinogen/thrombin (Primary)
  • Indications Craniocerebral trauma
  • Focus Therapeutic Use
  • Sponsors Ethicon

    • Most Recent Events

    • 14 Mar 2022 Status changed from recruiting to discontinued. Reason the study was stopped:Study completed the required elements (40 paediatric subjects) per regulatory requirement. Thestudy enrolled 40/42 subjects. No safety signals were identified. No changes required to the statistical analysis as described in the protocol.
    • 30 Mar 2021 Planned End Date changed from 31 Jul 2021 to 31 Jan 2022.
    • 30 Mar 2021 Planned primary completion date changed from 30 Jun 2021 to 31 Dec 2021.
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