N/A N=237 Randomized Single-blind Treatment

DuraSeal Sealant Post Market Study

Elective Cranial Procedures With Dural Incision

Bottom Line

View on ClinicalTrials.gov: NCT00704340 ↗

Enrolled (actual)

237

Serious AEs

14.4%

Results posted

Jul 2010

Primary outcome: 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 percent of subjects — p=.613

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DuraSeal Dural Sealant System (Device); Standard of Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Integra LifeSciences Corporation
Primary completion: May 2009

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

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).

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

View full record on ClinicalTrials.gov →

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.