This trial is active, not recruiting.

Condition dural sealing
Treatments duraseal exact spine sealant system, control
Phase phase 4
Sponsor Integra LifeSciences Corporation
Start date August 2011
End date December 2016
Trial size 931 participants
Trial identifier NCT01410864, COVDRSS0002


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery.
duraseal exact spine sealant system
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
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)
Devices or drugs used to seal the dura (other than DuraSeal)

Primary Outcomes

Post-operative CSF leaks
time frame: 90 days post-operative

Secondary Outcomes

Post-operative surgical site infections
time frame: 90 days post-operative
Post-operative neurological serious adverse events
time frame: 90 days post-operative

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title DuraSeal Exact Spine Sealant System Post-Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Integra LifeSciences Corporation.