Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Integra LifeSciences Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
