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Chest Wall Repair of Rib Fractures After Trauma

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00926991
First received: June 22, 2009
Last updated: March 21, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Rib Fractures
 Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • pain scales [ Time Frame: daily ] [ Designated as safety issue: No ]
  • ventilator requirement [ Time Frame: daily ] [ Designated as safety issue: No ]
  • hospital days [ Time Frame: discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
traumatic rib fractures Other: No intervention
No intervention; observation only

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:

  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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Vanderbilt University Trauma Center.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926991

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Jose J Diaz, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Jose J. Diaz, Jr., MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00926991     History of Changes
Other Study ID Numbers: Acute chest wall injuries
Study First Received: June 22, 2009
Last Updated: March 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries

ClinicalTrials.gov processed this record on May 22, 2013