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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040034 / PAS001 |
| Date Original Protocol Accepted |
04/07/2005
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| Date Current Protocol Accepted |
04/07/2005
|
| Study Name |
Duraseal
|
| Device Name |
DURASEAL DURAL SEALANT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The PAS is a prospective, randomized, single-blinded (patients), multi-center study to further characterize the DuraSeal Sealant as compared to "standard of care" in patients scheduled for cranial surgery that entails a dural incision.
|
| Study Population |
This device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.The study population includes subjects scheduled for clean, elective cranial surgery that entail dural incisions that are closed primarily with sutures with or without autologous duraplasty. To be eligible for the study, subjects had to be between 18 and 75 years of age, scheduled for an elective cranial procedure entailing a dural incision, and provided informed consent on an IRB approved consent form, and intra-operatively, there must have been evidence of non watertight closure after primary dural closure, either spontaneously or upon Valsalva maneuver, at 20 cm water for 5-10 seconds.
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| Sample Size |
250 patients; approximately 25 centers
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| Key Study Endpoints |
The primary outcome is the incidence of neurosurgical complications related to unplanned intervention (i.e., minimally invasive procedures) or return to the operating room. The secondary outcomes are 1) the incidence of post-operative surgical site infections within 30 days post-operation defined as (a) Superficial Incisional, (b) Deep Incisional, (c) Organ/Space; and 2) the presence or absence of CSF leaks within 30 days post-operation as determined from clinical diagnosis.
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| Follow-up Visits and Length of Follow-up |
Patients are followed for 30 days after treatment, and are evaluated clinically at discharge and at 30 days post-procedure.
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| Interim or Final Data Summary |
| Interim Results |
Study is completed. See Final Results
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| Actual Number of Patients Enrolled |
237 patients
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| Actual Number of Sites Enrolled |
17 centers
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| Patient Follow-up Rate |
98.30%
|
| Final Safety Findings |
There were 18 primary endpoint complications in 16 subjects: 9 happened in 8 patients in the DuraSeal group of which 6 (66.7%) were procedure related, 1 treatment related (11.1%), 1 not related and 1 unable to determine. Nine happened in 8 patients in the standard of care group: 7 (77.7%) were procedure related and 2 were treatment related (22.2%). All reported neurosurgical complications for the DuraSeal Sealant group are anticipated and expected. The incidence and nature of the complications that have been reported are consistent with the type and complexity of the procedures performed.
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| Study Strengths & Weaknesses |
High follow up rate. Randomized design.
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| Recommendations for Labeling Changes |
The sponsor updated the labeling to reflect the post-approval study results prior to FDA completing review of the final report. The lableing changes were also reviewed by FDA and the labeling does reflect the study results.
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