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Rib Fixation for Rib Fractures (SOFRIB Trial)
SOFRIB Trial Summary
This trial will compare two methods of treating patients with severe rib trauma. One group will receive standard care, which includes fixing the ribs. The other group will receive modern critical care, which focuses on pain control.
- Rib Fractures
- Flail Chest
SOFRIB Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SOFRIB Trial Design
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Who is running the clinical trial?
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- You have had chest surgery for reasons unrelated to the current study.Your bones have not healed properly after a fracture.You have three or more consecutive rib fractures in multiple locations, which is called flail chest.You have significant pain and difficulty performing daily activities, rated at 3 or higher on the FPS scale.You have a severe lung condition called Acute Respiratory Distress Syndrome.You have a physical abnormality or disability.You have experienced a wound that penetrates your chest.You are not able to breathe without the help of a ventilator.You have a long-term lung disease that requires you to use oxygen at home.You are addicted to opioids for a long time.You have a bone fracture that is less than 3cm away from your spine.You are currently experiencing severe shock.
- Group 1: Rib Fixation System
- Group 2: Critical Care and Pain Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the uppermost limit of participants in this research endeavor?
"To commence the trial, 236 individuals who adhere to the inclusion guidelines must volunteer. There are two possible sites for enrolment: Ocala Regional Medical Center - Health Trauma in Ocala, South carolina and Grand Strand Regional Medical Center in Myrtle Beach, Virginia."
How widely accessible is this trial?
"This research is presently recruiting participants from 6 different medical centres, located in Ocala, Myrtle Beach and Richmond, among other places. For those wishing to join the study, it would be advisable to pick a clinic that is closest to you so as to reduce travel requirements."
Do I meet the eligibility criteria to join this medical research?
"Qualification for this trial requires participants to have flail chest and be between 18-90 years old. Presently, the study is looking to accept up to 236 individuals."
Are there any vacancies remaining for participants in this experiment?
"The evidence stored on clinicaltrials.gov reveals that this medical test is currently searching for participants, having been initially posted in April 2015 and recently updated in May 2022."
Are individuals younger than age 50 being included in this research?
"This clinical trial is seeking individuals aged 18 and above, but under 90 years old."
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