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 - The Paediatric EVICEL® Neuro Study

Ethicon Inc0 sites42 target enrollmentMay 23, 2014

Overview

No summary available.

Registry

who.int

Start Date

May 23, 2014

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Preoperative
•1\. 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;
•2\. Administration of perioperative antibiotic prophylaxis;
•3\. Patients who are less than 18 years of age;
•4\. Patients who are able and willing to comply with the procedures required by the protocol;
•5\. 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.
•Intraoperative
•1\. Surgical wound classification Class I. Penetration of mastoid air cells during partial mastoidectomy is permitted;
•2\. 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.
•Are the trial subjects under 18? yes

•Preoperative:
•1\. Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.
•2\. Conditions or treatments significantly compromising the immune system (such as AIDS);
•3\. Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product;
•4\. Hydrocephalus (Occlusive Hydrocephalus is permitted when caused by posterior fossa pathology to be treated, i.e. hydrocephalus is due to a blockage caused by a tumor to be removed);
•5\. Existing CSF (ventricular, etc.) drains, Shunts, Cushing/Dandy cannulation or Burr holes which damage the dura.
•6\. Female subjects of childbearing potential with a positive urine or serum pregnancy test within 24 hours prior to surgery;
•7\. Female subjects who are breastfeeding, pregnant, or intend to become pregnant during the clinical study period;
•8\. Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment or expected during the study period;
•9\. Scheduled or foreseeable surgery within the follow\-up period.