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

Integra LifeSciences

Status: Completed

Conditions: Dural Sealing

Treatments: Other: Control; Device: DuraSeal Exact Spine Sealant System

Study type: Observational

Funder types: Industry

Identifiers

NCT01410864

COVDRSS0002

Details and patient eligibility

About

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.

Enrollment: 924 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

924 participants in 2 patient groups

DuraSeal Arm

Description:

Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery.

Treatment:

Device: DuraSeal Exact Spine Sealant System

Control Arm

Description:

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)

Treatment:

Other: Control