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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00298259
Registration number
NCT00298259
Ethics application status
Date submitted
1/03/2006
Date registered
2/03/2006
Date last updated
11/12/2012
Titles & IDs
Public title
Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
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Scientific title
Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
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Secondary ID [1]
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50/06
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Flail Chest
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Ventilation
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - operative fixation of fractured ribs
Active comparator: ORIF - open reduction internal fixation of fractured ribs in flail chest patients
No intervention: conservative management - current standard conservative management
Treatment: Surgery: operative fixation of fractured ribs
ORIFof fractured ribs in flail chest patients
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mechanical ventilation hours
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Assessment method [1]
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Timepoint [1]
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open
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Primary outcome [2]
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intensive care stay hours
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Assessment method [2]
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Timepoint [2]
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open
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Eligibility
Key inclusion criteria
* patients with multiple (>3) fractured ribs between the level of ribs 3 to 10 resulting in a paradoxical movement of the chest wall -
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* age > 75 years
* Spinal injuries which would preclude placement of the patient in a lateral decubitus position
* Open rib fractures with soiling or infection
* Severe head injury
* Uncorrected coagulopathy
* Adult respiratory distress syndrome
* Sepsis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2012
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Background: Fracture of several ribs in more than one place as the result of trauma, leads to paradoxical movement of the chest wall and ventilatory failure. The mainstay of management in these patients has traditionally been analgesia and positive pressure ventilation to splint the chest wall and allow healing of the ribs to begin. However, this management option leads to prolonged intensive care unit (ICU) stay with increasing complication rates as patients remain on a ventilator for prolonged periods. Patients often remain on a ventilator for two to three weeks while waiting for enough rib healing to provide sufficient chest wall stability to allow the patient to take over all their breathing themselves. Until that time, patients are at risk of pneumonia and sepsis and other complications. Long term disabilities which have been reported in these patients include ongoing pain syndromes, inability to return to work, particularly manual type labour and cosmetic chest wall deformities. An alternative treatment strategy is to operatively fix the ribs. By fixing the ribs operatively, the patient no longer requires internal pneumatic stabilization (provided by mechanical ventilation) and can be weaned from the ventilator within days rather than weeks. This can potentially lead to earlier discharge from the intensive care unit, and an avoidance of the multiple complications which arise in the ventilated patient. Rib fixation may also lead to less pain and deformity, improved mobility in the post injury phase and earlier return to work. Hypothesis: that early operative fixation of ribs in patients presenting with flail chest secondary to trauma will result in less mechanical ventilatory requirements, earlier discharge from the intensive care unit and lower rate of complications associated with prolonged mechanical ventilation. This will lead to cost savings in the treatment of these patients.
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Trial website
https://clinicaltrials.gov/study/NCT00298259
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Silvana Marasco, FRACS
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00298259
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