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NCT00704340 · ClinicalTrials.gov registry record · NA
DuraSeal Sealant Post Market Study
A NA study, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 237
- Enrollment target
NCT00704340: Completed NA study, sponsored by Integra LifeSciences Corporation.
NCT00704340 is a NA study that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 237 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00704340, a NA study, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 237 participants
- Enrollment target
Study 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).
Primary Outcome
Surgical Wound Complications; * Superficial incisional surgical site infection (SSI) * Deep incisional SSI * Organ/Space SSI * Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery * Poor wound healing Central Nervous System Events; * Cerebrospinal Fluid (CSF) leak * Hydrocephalus * Bacterial meningitis * Aseptic meningitis In addition, any complication related to the neurosurgical procedure that required unplanned interventi
Interventions
- OTHER Standard of Care
- DEVICE DuraSeal Dural Sealant System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-05 |
| Phase | NA |
What the finished NCT00704340 record still lists
NCT00704340 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT00704340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00704340 about?
NCT00704340 is a clinical study titled "DuraSeal Sealant Post Market Study". 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 sea...
What is the current status of trial NCT00704340?
This trial is currently completed. It is a NA study. The enrollment target is 237 participants. The study started on 2005-09. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00704340?
The interventions under investigation include: Standard of Care (OTHER), DuraSeal Dural Sealant System (DEVICE).
Who is sponsoring clinical trial NCT00704340?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00704340's enrollment target sits among peer trials
237 461st of 2000 higher than 1,540 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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