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General |
Study Status |
Other |
Application Number / Requirement Number |
P070005 / PAS001 |
Date Original Protocol Accepted |
03/06/2009
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Date Current Protocol Accepted |
03/06/2009
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Study Name |
REPEL CV
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Device Name |
REPEL-CV BIORESORBABLE ADHESION BARRIER
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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 |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs
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Detailed Study Protocol Parameters |
Study Objectives |
This is a multi-center, comparative, randomized study of REPEL-CV in pediatric patients (<21 years of age) undergoing cardiac procedures via sternotomy. The patient will be randomized to either treatment with REPEL-CV or no adhesion barrier.
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Study Population |
The population will be pediatric (<21 years of age) patients who are greater than 48 hours of age, requiring a first cardiovascular sternotomy procedure, on cardiopulmonary bypass and without delayed chest closure.
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Sample Size |
640 patients randomized and treated with either REPEL-CV (320 patients) or the untreated study-directed control (320 patients), 15 sites
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Key Study Endpoints |
The primary safety endpoint will be the incidence of a composite measure based on the patient-level incidence of the following two specific adverse events: 1) Re-operation for re-bleeding and/or cardiac tamponade; 2) Mediastinitis: defined as a deep sternal infection. The secondary safety endpoints will be: 1) The individual incidence of re-operation for re-bleeding and/or tamponade, and mediastinitis; 2) The specific incidence of mediastinitis, delayed constrictive pericarditis, sternal non-union, sternal dehiscence, and reoperation for bleeding and/or tamponade.
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Follow-up Visits and Length of Follow-up |
Patients will be followed for 6 months post initial sternotomy. However, patients who undergo a planned (staged) second sternotomy (not to include: emergent re-entry, or mediastinitis, or re-operation for re-bleeding and/or tamponade) within 6 months of the first sternotomy will be followed for 3 months post the planned second sternotomy.
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