This is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.
This study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. A study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. Randomization will be decided by a web-based computer program, accessible to the project coordinator. Although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. None of the subjects or study group members will be blinded since it is not possible to disguise the intervention. Patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
236
This intervention involves a surgical procedure to affix rib plates to broken ribs
Fort Walton Beach Medical Center
Fort Walton Beach, Florida, United States
ACTIVE_NOT_RECRUITINGLawnwood Regional Medical Center
Ft. Pierce, Florida, United States
RECRUITINGICU Length of Stay
length of stay in days
Time frame: measured through study completion, up to 2 years
Quality of Life, as determined by SF-36 survey
measured at 3 different time points post-hospital stay
Time frame: measured at 1 week, 3 months, 6 months post-intervention
Number of participants with pneumonia as defined by the Centers for Disease Control
based on classification as complication of rib trauma treatment
Time frame: measured monthly through course of study, up to 2 years
Total cost of treatments
measured based on total costs during length of hospital stay
Time frame: measured through study completion, up to 2 years
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Osceola Regional Medical Center
Kissimmee, Florida, United States
ACTIVE_NOT_RECRUITINGKendall Regional Medical Center
Miami, Florida, United States
RECRUITINGOcala Regional Medical Center - Health Trauma
Ocala, Florida, United States
RECRUITINGOrange Park Medical Center
Orange Park, Florida, United States
ACTIVE_NOT_RECRUITINGCentral Florida Regional Hospital
Sanford, Florida, United States
RECRUITINGResearch Medical Center
Kansas City, Missouri, United States
ACTIVE_NOT_RECRUITINGGrand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States
RECRUITINGChippenham Johnston-Willis Hospital
Richmond, Virginia, United States
RECRUITING