Back to resultsSurgical Stabilization for Rib Fractures (SSRF)
Primary Purpose
Trauma Chest, Rib Fracture Multiple
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
surgical stabilization
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Trauma Chest
Eligibility 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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early surgical stabilization
Usual care
Arm Description
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.
This arm will be usual care only. Usual care will include pain managment.
Outcomes
Primary Outcome Measures
Hospital Length of Stay
Number of days patient is in the hospital
Secondary Outcome Measures
Mortality
Death following trauma injury involving rib fractures
Incidence of respiratory failure requiring mechanical ventilation greater than 24 hours
number of patients who require mechanical ventilation greater than 24 hours
Incidence of tracheostomy
number of patients requiring a tracheostomy due to prolonged mechanical ventilation
Inpatient incidence of pneumonia
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
Number of patients utilizing regional anesthesia such as epidural, paravertebral, intercostal or serratus plane anesthesia
Opioid usage
Number of patients requiring opioid medications for pain control
Ventilator free days
Number of inpatient hospital days patients did not require mechanical ventilation
Intensive Care Unit (ICU) free days
Number of inpatient hospital days patient was not in ICU
Hospital (ICU) free days
Number of days patient was not in the hospital during the first 30 days after admission.
Re-intervention rates for surgical complications
The number of times a procedure was required to treat surgical complications
Health status at 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
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
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
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
Number of days from time of injury to time patient verbalized pain was resolved
Full Information
NCT ID
NCT04081233
First Posted
September 4, 2019
Last Updated
May 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT04081233
Brief Title
Surgical Stabilization for Rib Fractures
Acronym
SSRF
Official Title
The Effect of Early Stabilization of Rib Fractures on Patient-Centered Outcomes: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Chest, Rib Fracture Multiple
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early surgical stabilization
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
This arm will be usual care only. Usual care will include pain managment.
Intervention Type
Procedure
Intervention Name(s)
surgical stabilization
Other Intervention Name(s)
Rib plating
Intervention Description
Surgical procedure utilizing any commercially available internal rib fixation system
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Usual care typically consists of breathing exercises and pain control,often including opioids
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Number of days patient is in the hospital
Time Frame
180 days after admission
Secondary Outcome Measure Information:
Title
Mortality
Description
Death following trauma injury involving rib fractures
Time Frame
180 days after admission
Title
Incidence of respiratory failure requiring mechanical ventilation greater than 24 hours
Description
number of patients who require mechanical ventilation greater than 24 hours
Time Frame
24 hours after hospital admission
Title
Incidence of tracheostomy
Description
number of patients requiring a tracheostomy due to prolonged mechanical ventilation
Time Frame
Hospital discharge
Title
Inpatient incidence of pneumonia
Description
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
Time Frame
6 months after admission
Title
Utilization of regional anesthesia
Description
Number of patients utilizing regional anesthesia such as epidural, paravertebral, intercostal or serratus plane anesthesia
Time Frame
6 months after admission
Title
Opioid usage
Description
Number of patients requiring opioid medications for pain control
Time Frame
6 months post admission
Title
Ventilator free days
Description
Number of inpatient hospital days patients did not require mechanical ventilation
Time Frame
Hospital discharge
Title
Intensive Care Unit (ICU) free days
Description
Number of inpatient hospital days patient was not in ICU
Time Frame
Hospital discharge
Title
Hospital (ICU) free days
Description
Number of days patient was not in the hospital during the first 30 days after admission.
Time Frame
30 days post admission
Title
Re-intervention rates for surgical complications
Description
The number of times a procedure was required to treat surgical complications
Time Frame
180 days post admission
Title
Health status at 30 days post admission
Description
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 Frame
30 days post admission
Title
Health status at 90 days post admission
Description
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 Frame
90 days post admission
Title
Health status at 180 days post admission
Description
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 Frame
180 days post admission
Title
Time from injury to return to work or usual activity
Description
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 Frame
180 days post admission
Title
Time from injury to resolution of pain
Description
Number of days from time of injury to time patient verbalized pain was resolved
Time Frame
180 days post admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Meyer, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgical Stabilization for Rib Fractures
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