The Paediatric EVICEL® Neuro Study
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|ClinicalTrials.gov Identifier: NCT02309645|
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|CSF Leak||Biological: EVICEL® Fibrin Sealant Other: Sutures Only||Phase 4|
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 observation, diagnostic testing or the need for surgical intervention to treat a CSF leak or pseudomeningocele.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 1, 2014|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||July 1, 2019|
Experimental: EVICEL® Fibrin Sealant
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
Biological: EVICEL® Fibrin Sealant
Subjects randomized to receive EVICEL® Fibrin Sealant (Human), a thin layer will be applied to the entire length of the suture line and the adjacent area to at least 5mm away, including all suture holes.
Other Name: EVICEL, fibrin sealant
Subjects randomized to control will receive additional dural repair sutures as deemed necessary by the surgeon to attempt to achieve a watertight closure.
Other: Sutures Only
Subjects randomized to Control (Additional Sutures) will receive additional dural repair sutures applied immediately to the dural suture line after randomization as deemed necessary by the surgeon.
- 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 ]
- 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 ]
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): NCT02309645
|Contact: Leonie Rynn, MBA||908-218-2492||LRynn1@its.jnj.com|
|Clinical Investigation Site #22||Recruiting|
|Leeds, England, United Kingdom|
|Clinical Investigation Site #21||Active, not recruiting|
|Liverpool, England, United Kingdom|
|Clinical Investigation Site #25||Recruiting|
|London, England, United Kingdom|
|Clinical Investigation Site #23||Recruiting|
|Manchester, England, United Kingdom|
|Clinical Investigation Site #24||Recruiting|
|Edinburgh, Scotland, United Kingdom|
|Clinical Investigation Site #20||Recruiting|
|Oxford, United Kingdom|
|Study Director:||Richard Kocharian, MD, PhD||Ethicon, Inc.|