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Chest Wall Repair of Rib Fractures After Trauma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926991
First Posted: June 24, 2009
Last Update Posted: March 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
June 22, 2009
June 24, 2009
March 22, 2011
August 2009
August 2010   (Final data collection date for primary outcome measure)
  • pain scales [ Time Frame: daily ]
  • ventilator requirement [ Time Frame: daily ]
  • hospital days [ Time Frame: discharge ]
Same as current
Complete list of historical versions of study NCT00926991 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Chest Wall Repair of Rib Fractures After Trauma
Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study
This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.

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:

  1. Flail chest with/without failure to wean from the ventilator
  2. Significantly displaced rib fractures with/without lung impalement
  3. Symptomatic multiple rib fractures - Failure of pain control

Outcome measures to be evaluated include:

  1. Hospital Mortality
  2. Ventilator free days
  3. Need for tracheotomy
  4. Infectious Complications (pneumonia, bacteremia, UTI, empyema)
  5. Hospital & ICU Days
  6. Disposition following discharge
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Vanderbilt University Trauma Center.
Rib Fractures
Other: No intervention
No intervention; observation only
traumatic rib fractures
Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00926991
Acute chest wall injuries
No
Not Provided
Not Provided
Jose J. Diaz, Jr., MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Jose J Diaz, MD Vanderbilt University Medical Center
Vanderbilt University
March 2011