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OpenTrials
Completed

NCT Number: NCT01410864

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.

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Key information

Conditions

Dural Sealing Cerebrospinal Fluid Leak 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

Observational

Primary location

Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

DuraSeal Exact Spine Sealant System

Device

DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.

Control

Other

Devices or drugs used to seal the dura (other than DuraSeal)

Primary outcomes

  1. Post-operative CSF leaks

    Time frame: 90 days post-operative

Secondary outcomes

  1. Post-operative surgical site infections

    Time frame: 90 days post-operative

    Deep surgical site infections as defined by the Center for Disease Control criteria.

  2. Post-operative neurological serious adverse events

    Time frame: 90 days post-operative

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Acronym: DuraSeal PAS

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2011
Registry last updated
Mar 1, 2017

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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