NL-OMON36810
Completed
Phase 3
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL* as an Adjunct to Sutured Dural Repair - The Evicel Adjunct to Sutured Dural Repair Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- CSF leakage
- Sponsor
- Omrix Biopharmaceuticals Ltd
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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