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Clinical Trials/EUCTR2009-016501-41-BE
EUCTR2009-016501-41-BEActive, not recruitingPhase 1

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

Omrix Biopharmaceuticals Ltd0 sites135 target enrollmentStarted: February 17, 2010Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
135
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 80
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 55

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
  • •diagnosis of infection, fever, positive urine culture, positive blood
  • •culture, positive chest X-ray, evidence of infection along the planned
  • •surgical path. A WBC count of <20000 is permitted if the patient is being treated with steroids in the absence of all the other infection
  • •parameters.
  • •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.
  • •Non-compliant or insufficient treatment of diabetes mellitus in the
  • •opinion of the investigator.
  • •Hydrocephalus, except occlusive hydrocephalus caused by posterior
  • •fossa pathology to be treated.
  • •Existing CSF (ventricular, etc.) drains. 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, pregnant, 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.
  • •Scheduled or foreseeable surgery within the follow-up period.
  • •Intraoperative:
  • •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
  • •Chiari 1 subjects without injury to the arachnoid.
  • •Persistent signs of increased brain turgor
  • •Patient has a gap 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
  • •Two or more separate dura defects
  • •Major intraoperative complications that require resuscitation or
  • •deviation from the planned surgical procedure.

Investigators

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