N/A
Completed N=237
DuraSeal Sealant Post Market Study
Elective Cranial Procedures With Dural Incision
Source: ClinicalTrials.gov NCT00704340 ↗
Enrolled (actual)
237
Serious AEs
14.4%
Results posted
Jul 2010
Primary outcomePrimary: Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room. — 5.8; 7.7 percent of subjects — p=.613
Summary
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room. |
5.8; 7.7 | .613 |
| SECONDARY Percentage of Subjects With Post-operative Surgical Site Infections |
1.7; 2.6 | .681 |
| SECONDARY Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak |
0.8; 1.7 | .619 |
Eligibility Criteria
Inclusion Criteria
- Patient is between 18 and 75 years of age
- Patient is scheduled for an elective cranial procedure that entails a dural incision
- Evidence of intraoperative non-watertight closure
Data sourced from ClinicalTrials.gov (NCT00704340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.