A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL* as an Adjunct to Sutured Dural Repair

Phase 3

Completed

Conditions: CSF leakage
10040795
leakage of brain fluid

Registration Number: NL-OMON36810

Lead Sponsor: Omrix Biopharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Preoperative
1. Patient undergoing elective 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. After primary suture closure of the dural incision, CSF leakage will be evaluated during a Valsalva maneuver 20-25 cmH2O for 5-10 seconds.
2. Administration of perioperative antibiotic prophylaxis
3.Age ><= 18 yrs;Intraoperative
1. Surgical wound classification Class I (refer to Appendix II). 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.

Exclusion Criteria

Preoperative:
1. Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.;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 onlay patches after primary suture closure of the dura.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint will be the proportion of success (intraoperative<br /><br>watertight closure) in the treatment of persistent intraoperative CSF leakage<br /><br>following primary suture repair. Intraoperative watertight closure will be<br /><br>defined as no CSF leakage from the dural repair intraoperatively following the<br /><br>randomly assigned treatment with EVICEL or control (additional dural sutures),<br /><br>as assessed during a Valsalva maneuver 20-25 cmH2O for 5-10 seconds).<br /><br><br /><br>The safety endpoints include:<br /><br>- Incidence of CSF leakage within5 days (± 2) post-operatively.<br /><br>- Incidence of CSF leakage within 30 days (± 3) post-operatively.<br /><br>- Incidence of adverse events<br /><br>- Incidence of surgical site infections (SSI) according to National Healthcare<br /><br>Safety Network (NHSN) criteria within 30 days (± 3) post-operatively.</p><br>

Secondary Outcome Measures