Study Evaluating the safety and effectiveness of EVICEL® used for Suture-line sealing to provide a watertight closure during Paediatric Neurosurgical Procedures
- Conditions
- Subjects undergoing neurosurgical cranial procedures, requiring water-tight closures (suture-line sealing) in dura-mater during the surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-003558-26-GB
- Lead Sponsor
- Ethicon Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 42
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
Number of subjects for this age range: 42
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Intraoperative:
1. Dura injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dura cuff;
2. Use of implants made of synthetic materials coming into direct contact with dura (e.g., PTFE patches, shunts, ventricular and subdural drains);
3. Planned use of dural patches after primary suture closure of the dura;
4. Placement of Gliadel Wafers;
5. Persistent signs of increased brain turgor;
6. Patient has a gap between durotomy edges of greater than 2mm after primary dural closure.
7. Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dura resection;
8. Two or more separate dura defects, including defects from ventricular cannulation and ventricular-peritoneal shunting;;
9. Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: not applicable;Primary end point(s): Proportion of patients with successful (intraoperative watertight closure) in the treatment of intraoperative CSF leakage, defined as no CSF leakage from dural repair intraoperatively, during Valsalva maneuver 20 to25 cm H2O for 5 to 10 seconds.<br><br>;Timepoint(s) of evaluation of this end point: leakage at the dural suture line will be assessed intra-operatively after either EVICEL or additional sutures have been applied.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Incidence of CSF leakage within 5 days (± 2 days) post-operatively.<br>2. Incidence of CSF leakage within 30 days (± 3 days) post-operatively.<br>3. Incidence of adverse events<br>4. Incidence of surgical site infections (SSI) according to National Healthcare Safety Network (NHSN) criteria within 30 days (± 3 days) post-operatively<br><br>;Timepoint(s) of evaluation of this end point: 1. Incidence of CSF leakage within 5 days (± 2 days) post-operatively.<br>2. Incidence of CSF leakage within 30 days (± 3 days) post-operatively.<br>3. Incidence of adverse events<br>4. Incidence of surgical site infections (SSI) according to National Healthcare Safety Network (NHSN) criteria within 30 days (± 3 days) post-operatively<br>