Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01410864
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Tracking Information
First Submitted Date August 4, 2011
First Posted Date August 5, 2011
Last Update Posted Date March 1, 2017
Study Start Date August 2011
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2011)
Post-operative CSF leaks [ Time Frame: 90 days post-operative ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01410864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 4, 2011)
  • Post-operative surgical site infections [ Time Frame: 90 days post-operative ]
    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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DuraSeal Exact Spine Sealant System Post-Approval Study
Official Title DuraSeal Exact Spine Sealant System Post-Approval Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Dural Sealing
Intervention
  • 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)
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 28, 2017)
924
Original Estimated Enrollment
 (submitted: August 4, 2011)
1044
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01410864
Other Study ID Numbers COVDRSS0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Integra LifeSciences Corporation
Study Sponsor Integra LifeSciences Corporation
Collaborators Not Provided
Investigators Not Provided
PRS Account Integra LifeSciences Corporation
Verification Date February 2017