OBJECTIVE: To evaluate the safety and effectiveness of antibiotics in reducing the infectious complications following closed tube thoracostomy for isolated chest trauma. DESIGN: Double-blind, randomized clinical trial. SETTING:Medical school affiliated large urban teaching hospital and trauma center. PATIENTS: One hundred nineteen of 159 patients over 18 years old presenting to the emergency department requiring closed tube thoracostomy for isolated chest injuries (113 penetrating, 6 blunt). INTERVENTION: Patients received either placebo or 1 g cefonicid daily intravenously started at chest tube insertion and stopped within 24 h of removal. MEASUREMENTS AND RESULTS: The development of wound infections, pneumonia (CDC criteria), or empyema; the incidence of adverse events; length of hospitalization. One nonspecific infection was seen in the cefonicid group (1.6 percent) and six respiratory tract infections (10.7 percent) in the placebo group (three empyema, one empyema with pneumonia, two pneumonia) (p = 0.0505; p = 0.0094 [excluding nonspecific infection]). No significant differences with antibiotic use were seen in the duration of chest tube use (p = 0.766), peak WBC counts (p = 0.108), lower peak temperatures (p = 0.063), or length of hospitalization (p = 0.165). Patients who developed infectious complications averaged approximately 8 days longer hospitalization than those without (p < 0.0001). CONCLUSION: This study showed that patients receiving antibiotics had a significantly reduced rate of infection than did patients administered placebo. No significant adverse events were seen in either group.
RCT Entities:
OBJECTIVE: To evaluate the safety and effectiveness of antibiotics in reducing the infectious complications following closed tube thoracostomy for isolated chest trauma. DESIGN: Double-blind, randomized clinical trial. SETTING: Medical school affiliated large urban teaching hospital and trauma center. PATIENTS: One hundred nineteen of 159 patients over 18 years old presenting to the emergency department requiring closed tube thoracostomy for isolated chest injuries (113 penetrating, 6 blunt). INTERVENTION: Patients received either placebo or 1 g cefonicid daily intravenously started at chest tube insertion and stopped within 24 h of removal. MEASUREMENTS AND RESULTS: The development of wound infections, pneumonia (CDC criteria), or empyema; the incidence of adverse events; length of hospitalization. One nonspecific infection was seen in the cefonicid group (1.6 percent) and six respiratory tract infections (10.7 percent) in the placebo group (three empyema, one empyema with pneumonia, two pneumonia) (p = 0.0505; p = 0.0094 [excluding nonspecific infection]). No significant differences with antibiotic use were seen in the duration of chest tube use (p = 0.766), peak WBC counts (p = 0.108), lower peak temperatures (p = 0.063), or length of hospitalization (p = 0.165). Patients who developed infectious complications averaged approximately 8 days longer hospitalization than those without (p < 0.0001). CONCLUSION: This study showed that patients receiving antibiotics had a significantly reduced rate of infection than did patients administered placebo. No significant adverse events were seen in either group.