NCT01367951

Treatment of Acute, Unstable Chest Wall Injuries

A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 16 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Unstable chest injuries are common in poly trauma patients. They can lead to severe pulmonary restriction, loss of lung volume, difficulty with ventilation and can render the patient to require intubation and mechanical ventilation. Traditionally these injuries have been treated non-operatively, however in the past decade there has been numerous studies suggesting improved outcomes with surgical fixation. Surgical fixation can significantly decrease time spent in ICU as well as day on mechanical ventilation. The investigators aim is to conduct a randomized control trial of these injuries, to compare non-operative treatment with surgical fixation. The investigators' hypothesis is that surgically treated patient will have significantly improved outcomes compared to those treated non-operatively.

Conditions

• Blunt Injury of Thorax
• Flail Chest
• Chest Wall Injury Trauma
• Rib Fracture

Interventions

Type	Name	Description
PROCEDURE	Surgical fixation	* The fractures will be reduced and stabilized by use of plates and screws * Attempt will be made to stabilize ribs 3-7, as these are surgically accessible and most important in maintaining integrity of the chest cavity. * Goal is not to fix all the fractures, but to fix sufficient fractures to create an internal splint and allow chest wall motion to occur as a unit. In case of fibs fractured at numerous locations, as many fragments will be reduced and stabilized as necessary to ensure movement as a unit. * Chest tube(s) will be placed at the discretion of the treating surgeon in patients with pre-operative or intra-operative violation of the pleural cavity (ie pre-op pneumothorax/haemothorax, iatrogenic pleural injury). No post-operative drains will be inserted.

Timeline

• Start date: 2011-07-01
• Primary completion: 2018-12-01
• Completion: 2021-12-01
• First posted: 2011-06-07
• Last updated: 2021-06-18

Locations

1 site across 1 country: Canada