Clinical trial NCT01410864: DuraSeal Exact Spine Sealant System Post-Approval Study
Official title: DuraSeal Exact Spine Sealant System Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dural Sealing
Keywords: cerebrospinal fluid leaks
dural opening
dural sealing
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 924
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


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)

Primary outcomes:
measure: Post-operative CSF leaks
timeFrame: 90 days post-operative
Secondary outcomes:
measure: Post-operative surgical site infections
timeFrame: 90 days post-operative
measure: Post-operative neurological serious adverse events
timeFrame: 90 days post-operative
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Jose
country: United States
state: California
city: Stanford
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: East Syracuse
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Bend
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Plano
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References: