Chest Wall Repair of Rib Fractures After Trauma

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926991
• Other study ID #: Acute chest wall injuries
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: March 21, 2011
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rib Fractures

Intervention

Other:
• No intervention
No intervention; observation only

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scales		daily	No
Primary	ventilator requirement		daily	No
Primary	hospital days		discharge	No