Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 1, 2006 | ||||
| Last Updated Date | December 9, 2012 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00298259 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest | ||||
| Official Title ICMJE | Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Procedure: operative fixation of fractured ribs
ORIFof fractured ribs in flail chest patients |
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 48 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00298259 | ||||
| Other Study ID Numbers ICMJE | 50/06 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Silvana Marasco, The Alfred | ||||
| Study Sponsor ICMJE | The Alfred | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | The Alfred | ||||
| Verification Date | December 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||