SSRF: Surgical Stabilization for Rib Fractures
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early surgical stabilization This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management. |
Procedure: surgical stabilization
Surgical procedure utilizing any commercially available internal rib fixation system
Other Names:
|
| Active Comparator: Usual care This arm will be usual care only. Usual care will include pain managment. |
Procedure: Usual care
Usual care typically consists of breathing exercises and pain control,often including opioids
|
Outcome Measures
Primary Outcome Measures
- Hospital Length of Stay [180 days after admission]
Number of days patient is in the hospital
Secondary Outcome Measures
- Mortality [180 days after admission]
Death following trauma injury involving rib fractures
- Incidence of respiratory failure requiring mechanical ventilation greater than 24 hours [24 hours after hospital admission]
number of patients who require mechanical ventilation greater than 24 hours
- Incidence of tracheostomy [Hospital discharge]
number of patients requiring a tracheostomy due to prolonged mechanical ventilation
- Inpatient incidence of pneumonia [6 months after admission]
number of patients diagnosed with pneumonia with greater than 10,000 cfu/ml on bronchioalveolar lavage or clinical diagnosis of pneumonia with subsequent antibiotic coverage
- Utilization of regional anesthesia [6 months after admission]
Number of patients utilizing regional anesthesia such as epidural, paravertebral, intercostal or serratus plane anesthesia
- Opioid usage [6 months post admission]
Number of patients requiring opioid medications for pain control
- Ventilator free days [Hospital discharge]
Number of inpatient hospital days patients did not require mechanical ventilation
- Intensive Care Unit (ICU) free days [Hospital discharge]
Number of inpatient hospital days patient was not in ICU
- Hospital (ICU) free days [30 days post admission]
Number of days patient was not in the hospital during the first 30 days after admission.
- Re-intervention rates for surgical complications [180 days post admission]
The number of times a procedure was required to treat surgical complications
- Health status at 30 days post admission [30 days post admission]
Health status measured by the patients answers to the EuroQol-5D-5L questionnaire which is based in a scale form 0-100 with higher scores indicating a better outcome.
- Health status at 90 days post admission [90 days post admission]
Health status measured by the patients answers to the EuroQol-5D-5L questionnaire which is based in a scale form 0-100 with higher scores indicating a better outcome.
- Health status at 180 days post admission [180 days post admission]
Health status measured by the patients answers to the EuroQol-5D-5L questionnaire which is based in a scale form 0-100 with higher scores indicating a better outcome.
- Time from injury to return to work or usual activity [180 days post admission]
Number of days from time of injury until patient was able to return to work or usual activities prior to injury per patient's assessment
- Time from injury to resolution of pain [180 days post admission]
Number of days from time of injury to time patient verbalized pain was resolved
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Blunt trauma mechanism
-
Severe chest wall injury (defined by one of the 3 below):
Radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement
- At least one true rib (1-7) fractured and accessible for stabilization
Exclusion Criteria:
-
Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours)
-
Spinal cord injury
-
Pre-existing congestive heart failure or oxygen-dependent pulmonary disease
-
Any reason for which SSRF could not occur within 72 hours of admission
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- National Center for Advancing Translational Science (NCATS)
Investigators
- Principal Investigator: David Meyers, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-19-0649
- KL2TR003168