N/A N=98 Randomized Single-blind Treatment

Study to Evaluate Safety & Effectiveness of Spinal Sealant

Cerebrospinal Fluid Leakage, Subdural

Bottom Line

View on ClinicalTrials.gov: NCT00444067 ↗

Enrolled (actual)

Serious AEs

22.7%

Results posted

Aug 2012

Primary outcome: Primary: Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) — 98.0; 79.2 percentage of participants

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)	98.0; 79.2	—

Summary

To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Eligibility Criteria

Inclusion Criteria

Subjects scheduled for a spinal procedure that requires a dural incision

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00444067). 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.