The Paediatric EVICEL® Neuro Study (NCT02309645) | Clinical Trial Compass
TerminatedPhase 3
The Paediatric EVICEL® Neuro Study
Stopped: Study completed the required elements (40 paediatric subjects) per regulatory requirement. The study enrolled 40/42 subjects. No safety signals were identified. No changes required to the statistical analysis as described in the protocol.
United Kingdom40 participantsStarted 2014-10-01
Plain-language 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.
Who can participate
Age range17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient undergoing elective or urgent craniotomy/craniectomy for pathological processes in the posterior fossa (such as benign or malignant tumors, vascular malformation, and Chiari 1 malformations) or in the supratentorial region and who are demonstrated to have persistent CSF leakage following primary attempt at suture closure of the dural incision;
* Administration of perioperative antibiotic prophylaxis;
* Patients who are less than 18 years of age;
* Patients who are able and willing to comply with the procedures required by the protocol;
* The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. In addition, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial.
* Surgical wound classification Class I (refer to Appendix II). Penetration of mastoid air cells during partial mastoidectomy is permitted;
* The cuff of native dura along the craniotomy edge on each side is wide enough based on surgeon's judgment to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
Exclusion Criteria:
* Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage;
* Conditions or treatments significantly compromising the immune system (such as AIDS);
* Known hypersensitivity t…
What they're measuring
1
Percentage of Participants With Success (Intraoperative Watertight Closure) in the Treatment of Intraoperative Cerebrospinal Fluid (CSF) Leakage