- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00926991
Chest Wall Repair of Rib Fractures After Trauma
Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study
Study Overview
Detailed Description
Hypothesis:
Rib fracture repair utilizing open reduction and internal fixation with commercially available rib plating systems improves outcomes (i.e., infectious complications), decreases hospital stay and mortality.
Study Design:
This is a prospective, observational study of 50 patients who, due to their injury pattern, are operative candidates for open reduction and internal fixation with commercial available rib plating systems for one of the following indications:
- Flail chest with/without failure to wean from the ventilator
- Significantly displaced rib fractures with/without lung impalement
- Symptomatic multiple rib fractures - Failure of pain control
Outcome measures to be evaluated include:
- Hospital Mortality
- Ventilator free days
- Need for tracheotomy
- Infectious Complications (pneumonia, bacteremia, UTI, empyema)
- Hospital & ICU Days
- Disposition following discharge
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
traumatic rib fractures
|
No intervention; observation only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain scales
Time Frame: daily
|
daily
|
ventilator requirement
Time Frame: daily
|
daily
|
hospital days
Time Frame: discharge
|
discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jose J Diaz, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acute chest wall injuries
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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