Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy

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

Population: Intent-to-Treat (ITT) Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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)

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

The number of participants who needed any additional non-study antibiotics for any reason after randomization.

Time frame: Up to 28 days after surgery

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

The number of participants with an allergic reaction to a drug.

Time frame: Up to 28 days after surgery

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.

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)

Population: ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.