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OpenTrials
Completed

NCT Number: NCT00926991

Chest Wall Repair of Rib Fractures After Trauma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention; observation only

Primary outcomes

  1. pain scales

    Time frame: daily

  2. ventilator requirement

    Time frame: daily

  3. hospital days

    Time frame: discharge

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Chest Wall Stabilization for Traumatic Chest Wall Injuries: An Observational Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 24, 2009
Registry last updated
Mar 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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