DuraSeal Exact Spine Sealant System Post-Approval Study (DuraSeal PAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Integra LifeSciences Corporation
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01410864
First received: August 4, 2011
Last updated: June 30, 2014
Last verified: June 2014

August 4, 2011
June 30, 2014
August 2011
December 2016   (final data collection date for primary outcome measure)
Post-operative CSF leaks [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01410864 on ClinicalTrials.gov Archive Site
  • Post-operative surgical site infections [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]
    Deep surgical site infections as defined by the Center for Disease Control criteria.
  • Post-operative neurological serious adverse events [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
DuraSeal Exact Spine Sealant System Post-Approval Study
DuraSeal Exact Spine Sealant System Post-Approval Study

This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

DuraSeal group will be patients that undergo a spinal procedure where a dural opening occurrs and is treated with DuraSeal Exact Spine Sealant System. Control group will be patients that have undergone a spinal procedure where a dural opening occurred and was treated with anything other than DuraSeal Sealant (Spine or Dural). These subjects may be enrolled retrospectively (through a chart review of past cases) or prospectively.

Dural Sealing
  • Device: DuraSeal Exact Spine Sealant System
    DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
  • Other: Control
    Devices or drugs used to seal the dura (other than DuraSeal)
  • DuraSeal Arm
    Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery.
    Intervention: Device: DuraSeal Exact Spine Sealant System
  • Control Arm
    Subjects who have undergone a spinal procedure where techniques other than DuraSeal were administered for the treatment of either an intentional or incidental opening of the dura may be enrolled either prospectively or retrospectively (via medical record screening)
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
884
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is 18 years of age or older
  • Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:

    • DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR
    • Any other method of sealing the dura with the exception of DuraSeal™ Sealant -either spinal or cranial. (Control group ONLY)
  • Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.

    • Prospective subjects: Consent must be obtained within 24 hours of surgery stop time.
    • Retrospective subjects (Control group specific): IRB approval may be granted to individual sites to waive requirement for informed consent.

Exclusion Criteria:

  • The investigator determines that the subject will not be able to comply with the required follow-up visits (not required if subject is being enrolled retrospectively- control group ONLY)
  • Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)
Both
18 Years and older
No
Contact: Sheila Smith 781-565-1334 sheila.smith@integralife.com
Contact: Stefani Battaglia 781-565-1265 stefani.battaglia@integralife.com
United States
 
NCT01410864
COVDRSS0002
No
Integra LifeSciences Corporation
Integra LifeSciences Corporation
Not Provided
Not Provided
Integra LifeSciences Corporation
June 2014

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