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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.
Trauma Research & Education Foundation of Fresno
Fresno, California, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States
Morbidity
total days on ventilator, ICU length of stay, hospital length of stay
Time frame: Measured daily during hospitalization (approx 1 month)
Mortality
Number of participants who died during any hospital stay.
Time frame: Measured any time during hospital stay (approx 30 days)
Quality of Life
Rand 36 health survey.
Time frame: Measured at 3 and 6 months post-discharge
Pulmonary Function
Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).
Time frame: Measured at 3 and 6 months post-discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Tennessee
Knoxville, Tennessee, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States