The Paediatric EVICEL® Neuro Study
Condition: CSF Leak
MeSH terms: Cerebrospinal Fluid Leak
Intervention: EVICEL® Fibrin Sealant; Sutures Only
Intervention description: 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.; 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.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: fibrin sealant; CSF leak

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.
    

Eligibility criteria:

        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 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;

          -  Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology to
             be treated.

          -  Existing CSF (ventricular, etc.) drains, shunts, Cushing/Dandy cannulation or Burr
             holes which damage the dura;

          -  Female subjects of childbearing potential with a positive urine or serum pregnancy
             test within 24 hours prior to surgery;

          -  Female subjects who are breastfeeding or intend to become pregnant during the clinical
             study period;

          -  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;

          -  Scheduled or foreseeable surgery within the follow-up period.

          -  Dura injury during craniotomy/craniectomy that cannot be eliminated by widening the
             craniotomy/craniectomy to recreate the native dura cuff;

          -  Use of implants made of synthetic materials coming into direct contact with dura
             (e.g., PTFE patches, shunts, ventricular and subdural drains);

          -  Planned use of dural patches after primary suture closure of the dura;

          -  Placement of Gliadel Wafers;

          -  Persistent signs of increased brain turgor;

          -  Patient has a gap between durotomy edges of greater than 2mm after primary dural
             closure.

          -  Intersecting durotomy scars in the surgical path from a previous operation that cannot
             be completely removed by the planned dura resection;

          -  Two or more separate dura defects;

          -  Major intraoperative complications that require resuscitation or deviation from the
             planned surgical procedure.