Chest Wall Repair of Rib Fractures After Trauma
- Conditions
- Rib Fractures
- Interventions
- Other: No intervention
- Registration Number
- NCT00926991
- Lead Sponsor
- Vanderbilt University
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description traumatic rib fractures No intervention -
- Primary Outcome Measures
Name Time Method ventilator requirement daily pain scales daily hospital days discharge
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States