Flail Chest Clinical Trial
Official title:
Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study
The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment.
Chest trauma is frequent in the multiply-injured patient and is directly responsible for
20-25% of trauma deaths. Additionally, chest trauma is a major contributory factor in
another 25% of deaths after trauma. Besides short term mortality, injuries to the chest
result in significant morbidity and cost of care and long term disability. Among patients
sustaining chest trauma, flail chest is one of the more serious injuries. Patients require
prolonged ventilation, ICU and hospital stays and have a high incidence of pulmonary
infections. Survivors often go on to have significant impairment of pulmonary function and
over half may never return to gainful employment.
The standard therapy of injuries to the chest wall, including flail chest has been effective
analgesia, pulmonary toilet with postural drainage and aggressive chest physical therapy.
Despite these measures, flail chest patients often do not do well. Early operative fixation
(surgical anchoring and bracing of bones) to stabilize the chest wall and restore pulmonary
dynamics has always been an attractive option. With improvements in patient selection,
availability of good modern anesthesia and critical care, and mechanical fixation devices,
small studies and several case reports testify to the feasibility of the concept and
possible short and long term benefits. All but one small institutional study are
retrospective in nature limiting the generalizability of the conclusions. In that small
single institutional prospective trial in which patients with flail chest were randomized to
either early operative fixation or standard non-operative therapy, patients randomized to
early operative fixation showed significant improvements in both short- and long-term health
outcomes resulting in lower in-hospital costs in the surgically treated group. Despite these
very impressive results, although prospective, it is one study with a small number of
patients from a single institution. The question of the benefits of operative fixation can
only be conclusively answered by a larger multi-institutional prospective randomized study.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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