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NCT Number: NCT01174992

A 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.

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Key information

Conditions

Dura Defects Cerebrospinal Fluid Leak Cerebrospinal Fluid Otorrhea Craniocerebral Trauma Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Neurosurgery, Ziekenhuis Oost Limburg, Genk, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVICEL

Biological

EVICEL is a human plasma derived fibrin sealant

Sutures only

Other

Standard of care

Primary outcomes

  1. Proportion of success

    Time frame: Day 1 (intraoperative)

    Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.

Secondary outcomes

  1. Incidence of CSF leakage

    Time frame: Day 5 post-op

  2. Incidence of CSF leakage

    Time frame: Day 30 post-op

  3. Incidence of adverse events

    Time frame: up to 30 days post-op

  4. Incidence of surgical site infections

    Time frame: Day 5 and 30 post-op

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Collaborators

  • OMRIX Biopharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2010
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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