Clinical Trial: The Paediatric EVICEL® Neuro Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for suture-line sealing in dura-mater closure in elective or urgent paediatric cranial neurosurgery to provide intraoperative watertight closure.

Detailed Summary:

This is a prospective randomized, open-label, multi-center controlled study evaluating the effectiveness of EVICEL® as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.

Paediatric subjects, undergoing elective or urgent craniotomy/craniectomy for pathological processes in the posterior fossa (such as benign or malignant tumors, vascular malformations, and Chiari 1 malformations) or in the supratentorial region and who were demonstrated to have persistent cerebrospinal fluid (CSF) leakage following a primary attempt at suture closure of the dural incision.

Paediatric subjects for this study are classified as:

  • Newborn infants (birth to 27 days. Pre-term newborn infants born ≤ 37 weeks gestation will be included within the group)
  • Infants and toddlers (28 days to <24 months)
  • Children (2 to 11 years)

  • Adolescents (12 to <18 years)

    42 paediatric subjects with intra-operative cerebrospinal fluid (CSF) leak following primary suturing of the dura will be randomized in a 2:1 allocation ratio and will be stratified by surgical procedure, posterior fossa or supratentorial to either EVICEL® Fibrin Sealant (Human) or additional dural sutures.

Subjects will be followed post-operatively through discharge and for 30 days (±3 days) post-surgery. The incidence of CSF leaks will be assessed within 5 days (± 2 days) and 30 days (±3 days) post-operatively as detected by any of the following: clinical observatio
Sponsor: Ethicon, Inc.

Current Primary Outcome: Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage defined as no cerebrospinal (CSF) leakage from dural repair intraoperatively, during Valsalva maneuver 20-25 cm H2O for 5-10 seconds. [ Time Frame: Intraoperative ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of CSF leakage within 5 days (± 2 days) post-operatively. [ Time Frame: Up to 5 days post-operatively ]
  • Incidence of CSF leakage within 30 days (± 3 days) post-operatively. [ Time Frame: Up to 30 days post-operatively ]
  • Incidence of adverse events [ Time Frame: Intaoperative through the 30-day follow-up ]
  • Incidence of surgical site infections (SSI) according to National Healthcare Safety Network (NHSN) criteria within 30 days (± 3 days) post-operatively [ Time Frame: Intaoperative through the 30-day follow-up ]


Original Secondary Outcome:

  • Incidence of CSF leakage within 5 days (± 2 days) post-operatively. [ Time Frame: Up to 5 days post-operatively ]
  • Incidence of CSF leakage within 30 days (± 3 days) post-operatively. [ Time Frame: Up to 30 days post-operatively ]
  • Incidence of adverse events [ Time Frame: Intaoperative through the 30-day follow-up ]
  • Incidence of surgical site infections (SSI) [ Time Frame: Intaoperative through the 30-day follow-up ]


Information By: Ethicon, Inc.

Dates:
Date Received: October 2, 2014
Date Started: October 1, 2014
Date Completion: July 1, 2019
Last Updated: May 2, 2017
Last Verified: May 2017