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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00926991 |
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Date of registration:
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22/06/2009 |
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Primary sponsor: |
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Public title:
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Chest Wall Repair of Rib Fractures After Trauma
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Scientific title:
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Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00926991 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Jose J Diaz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects must be at least >18 years of age
- Subjects must have one of the following clinical indications:
- >3 rib flail segments with paradoxical chest wall movement
- Non-repair of defect may result in pulmonary hernia
- Minimal associated injuries
- Severely displaced fractures are significantly impeding lung expansion.
- Failure of narcotics or epidural pain catheter to control pain
Exclusion Criteria:
- Significant pulmonary contusion
- Significant brain injury (AIS 4 and/or ICP monitoring)
- Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization
- Subjects not expected to survive the 90-day follow-up period
- Known pregnancy
- Prisoners
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rib Fractures
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Intervention(s)
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Other: No intervention
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Primary Outcome(s)
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hospital days
[Time Frame: discharge]
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pain scales
[Time Frame: daily]
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ventilator requirement
[Time Frame: daily]
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Secondary ID(s)
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Acute chest wall injuries
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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