Clinical Trial: Rib Fixation for Clinically Severe Rib Fractures From Trauma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Darwin Ang
Current Primary Outcome: ICU Length of Stay [ Time Frame: measured through study completion, up to 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of Life, as determined by SF-36 survey [ Time Frame: measured at 1 week, 3 months, 6 months post-intervention ]measured at 3 different time points post-hospital stay
- Number of participants with pneumonia as defined by the Centers for Disease Control [ Time Frame: measured monthly through course of study, up to 2 years ]based on classification as complication of rib trauma treatment
- Total cost of treatments [ Time Frame: measured through study completion, up to 2 years ]measured based on total costs during length of hospital stay
Original Secondary Outcome: Same as current
Information By: SCRI Development Innovations, LLC
Dates:
Date Received: April 30, 2015
Date Started: April 2015
Date Completion: June 2019
Last Updated: May 2, 2017
Last Verified: May 2017