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

This study has been completed.
Sponsor:
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01174992
First received: August 3, 2010
Last updated: June 19, 2012
Last verified: June 2012
History of Changes

August 3, 2010
June 19, 2012
July 2010
September 2011   (final data collection date for primary outcome measure)
Proportion of success [ Time Frame: Day 1 (intraoperative) ] [ Designated as safety issue: Yes ]
Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.
Same as current
Complete list of historical versions of study NCT01174992 on ClinicalTrials.gov Archive Site
  • Incidence of CSF leakage [ Time Frame: Day 5 post-op ] [ Designated as safety issue: Yes ]
  • Incidence of CSF leakage [ Time Frame: Day 30 post-op ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: up to 30 days post-op ] [ Designated as safety issue: Yes ]
  • Incidence of surgical site infections [ Time Frame: Day 5 and 30 post-op ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Dura Defects
  • Biological: Evicel
    EVICEL is a human plasma derived fibrin sealant
  • Other: Sutures only
    Standard of care
  • Experimental: Evicel
    Intervention: Biological: Evicel
  • Sutures only
    Intervention: Other: Sutures only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
October 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient undergoing elective craniotomy/craniectomy
  • Age greater than or equal to 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.

Exclusion Criteria:

  • Chemotherapy or radiation therapy within 7 days following surgery.
  • Conditions compromising the immune system.
  • 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.
  • Female subjects of childbearing potential with a positive pregnancy test prior to surgery.
  • Female subjects who are breastfeeding 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.
  • Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Netherlands,   United Kingdom
 
NCT01174992
400-09-001, 2009-016501-41
No
Ethicon, Inc.
Ethicon, Inc.
OMRIX Biopharmaceuticals
Study Director: James Hart, MD Ethicon, Inc.
Ethicon, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP