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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
Scientific title
Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
Secondary ID [1] 0 0
50/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Flail Chest 0 0
Ventilation 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mechanical ventilation hours
Timepoint [1] 0 0
open
Primary outcome [2] 0 0
intensive care stay hours
Timepoint [2] 0 0
open

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 -
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00298259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Silvana Marasco, FRACS
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00298259