EUCTR2009-016501-41-BE
Active, not recruiting
Phase 1
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair
DrugsEvicel
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Omrix Biopharmaceuticals Ltd
- Enrollment
- 135
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preoperative
- •Patient undergoing elective craniotomy/craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformation, and Chiari 1 malformations) or in the supratentorial region and who are demonstrated to have persistent CSF leakage following suture closure of the dural incision. CSF leakage will be evaluated during a period of Valsalva of 20\-25 cm of H20 for 5\-10 seconds.
- •Administration of perioperative antibiotic prophylaxis
- •Age \>\= 18 years
- •Patients who are able and willing to comply with the procedures required by the protocol.
- •Signed and dated written informed consent from the subject or from his/her legal representative prior to any study\-related procedures.
- •Intraoperative
- •Surgical wound classification Class I. Penetration of mastoid air cells during partial mastoidectomy is permitted.
- •The cuff of native dura along the craniotomy edge is wide enough based on the surgeon's judgement to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •Preoperative:
- •Subjects with a dura lesion from a recent surgery that still has the
- •potential for CSF leakage.
- •Chemotherapy scheduled within 7 days following surgery.
- •Radiation therapy to the head scheduled within 7 days following
- •Long\-term (6 months) low dose steroid therapy for existing
- •chronic/inflammatory conditions to be resumed within 7 days following
- •surgery. However, postoperative tapered high\-dose steroids are
- •Subjects with severely altered renal function as confirmed by local lab reference ranges for serum creatinine and/or hepatic function \[ALT, AST \> 5 x upper limit of norm (ULN)]
- •Evidence of an infection indicated by any one of the following: clinical
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL* as an Adjunct to Sutured Dural RepairCSF leakageleakage of brain fluid10040795NL-OMON36810Omrix Biopharmaceuticals Ltd20
Active, not recruiting
Not Applicable
An investigation of Evicel sealant to assist brain surgeryTissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral surgery.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2009-016501-41-FIOmrix Biopharmaceuticals Ltd135
Active, not recruiting
Not Applicable
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repairtissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral surgery.EUCTR2009-016501-41-DEOmrix Biopharmaceuticals Ltd130
Active, not recruiting
Phase 1
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural RepairEUCTR2009-016501-41-GBOmrix Biopharmaceuticals Ltd139
Active, not recruiting
Phase 1
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural RepairTissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral surgery.EUCTR2009-016501-41-NLOmrix Biopharmaceuticals Ltd139