Treatment of Acute, Unstable Chest Wall Injuries

NCT01367951 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2021-06-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER
  • Hamilton Health Sciences Corporation

    collaborator OTHER
  • Vancouver General Hospital

    collaborator OTHER
  • Eastern Health

    collaborator OTHER
  • The Ottawa Hospital

    collaborator OTHER
  • Alberta Health services

    collaborator OTHER
  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Michael D McKee, MD, FRCS(C) · St. Michael's Hospital, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2018-12-31
Completion
2021-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01367951 on ClinicalTrials.gov