The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decreases infectious complications when compared to pre-operative antibiotics alone, in patients undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).
There is currently no evidence-based standard for the extended use of prophylactic antibiotics in patients receiving thoracic surgery that results in the placement of a tube thoracostomy (chest tube). The rationale for this prophylaxis is that antibiotics directed at typical skin flora may reduce the rate of infectious complications, such as surgical site infection and empyema. Currently, clinicians' approach to post-operative antibiotic prophylaxis in patients undergoing tube thoracostomy associated with thoracic and cardio-thoracic surgery varies widely. While reducing the infectious complications of thoracic surgery is an important goal, it is also important to reduce the use of unnecessary antibiotics. As there is equipoise on the benefit of extended antibiotic prophylaxis for tube thoracostomy, our study will examine two prevailing clinical practices and attempt to determine if one leads to better patient outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
251
Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were penicillin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Brigham & Women's Hospital
Boston, Massachusetts, United States
Number of Participants Who Experienced At Least One Postoperative Infectious Complication
Infectious complications include: surgical site infection, empyema, pneumonia, and the occurrence of Clostridium difficile colitis within 28 days of surgery. Participants are only counted once regardless of how many different infectious complications they had.
Time frame: Up to 28 days after surgery
Number of Participants Who Experienced Surgical Site Infection
Surgical Site Infection: 1. Superficial surgical site infection - involves only skin or subcutaneous tissue around incision and has at least one of the following criteria: * purulent drainage * organisms isolated from aseptically obtained culture * pain or tenderness, localized swelling, redness or heat and the incision deliberately opened by a surgeon * diagnosis of a superficial wound infection by a surgeon 2. Deep surgical site infection - involves deep soft tissues e.g. fascia or muscle and has at least one of the following: * purulent drainage from the incision but not from the organ/space of the surgical site * deep incision spontaneously dehisces or deliberately opened by surgeon when patient has at least one of following signs or symptoms - fever (\>38°C), localized pain or tenderness. * an abscess or evidence of infection involving incision is found on direct examination, histopathologic or radiographic examination * diagnosis of a deep wound infection
Time frame: Up to 28 days after surgery
Number of Participants Who Experienced Pneumonia
Pneumonia: A new infiltrate on chest x-ray associated with at least three of the following: * fever (\>38°C) * purulent sputum * leukopenia (white blood cell \[WBC\] count of \<4000/µL) or leukocytosis (WBC count of \>11000/µL) * sputum culture with pathogenic bacteria * increased oxygen requirements
Time frame: Up to 28 days after surgery
Number of Participants Who Experienced Empyema
Empyema: Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (\>38°C).
Time frame: Up to 28 days after surgery
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Number of Participants Who Experienced Clostridium (C) Difficile Colitis
C. Difficile Colitis: Positive for C difficile toxin assay results and any 1 of the following: * new diarrhea * ileus or toxic megacolon * leukopenia (WBC count of \<4000/µL) or leukocytosis (WBC count of \>11000/µL) * findings from sigmoidoscopy, colonoscopy, or histopathologic examination consistent with C difficile infection
Time frame: Up to 28 days after surgery
Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery
The number of participants who needed any additional non-study antibiotics for any reason after randomization.
Time frame: Up to 28 days after surgery
Number of Participants Who Needed Reoperation
The number of participants who needed reoperations for any reason from the time after the first surgery to the end of the 28-day follow-up period.
Time frame: Up to 28 days after surgery
Length of Hospital Stay
The length of hospital stay is the number of days the participant remained in the hospital.
Time frame: From day of surgery to discharge (up to 35 days)
Time to Removal of Chest Tubes
Time to removal of chest tubes is the number of days from the time of chest tube placement to time they were removed.
Time frame: From day of surgery to removal of chest tubes (up to 33 days)
Number of Participants With Allergic Reactions
The number of participants with an allergic reaction to a drug.
Time frame: Up to 28 days after surgery
All-Cause Mortality
All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause.
Time frame: Up to 28 days after surgery