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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00818766
• Collaborator: (none)
• Enrollment: 251
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Antibiotic Prophylaxis	Drug: cefazolin or vancomycin; Drug: Placebo	N/A

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 251 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Extended Antibiotic Prophylaxis for the Prevention of Infectious Complications Associated With Tube Thoracostomy in Patients Undergoing Elective General Thoracic Surgery: A Double-Blind, Placebo-Controlled, Randomized Trial
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antibiotic Participants received intravenous (IV) cefazolin or vancomycin (for participants allergic to cephalosporin) immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.	Drug: cefazolin or vancomycin; 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.; Other Names: Cefazolin (Ancef) Vancomycin (Vancocin)
Placebo Comparator: Placebo Participants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.	Drug: Placebo; Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced At Least One Postoperative Infectious Complication [Up to 28 days after surgery]

   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.

2. Number of Participants Who Experienced Surgical Site Infection [Up to 28 days after surgery]

   Surgical Site Infection: 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 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

3. Number of Participants Who Experienced Pneumonia [Up to 28 days after surgery]

   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

4. Number of Participants Who Experienced Empyema [Up to 28 days after surgery]

   Empyema: Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (>38°C).

5. Number of Participants Who Experienced Clostridium (C) Difficile Colitis [Up to 28 days after surgery]

   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

Secondary Outcome Measures

1. Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery [Up to 28 days after surgery]

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

2. Number of Participants Who Needed Reoperation [Up to 28 days after surgery]

   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.

3. Length of Hospital Stay [From day of surgery to discharge (up to 35 days)]

   The length of hospital stay is the number of days the participant remained in the hospital.

4. Time to Removal of Chest Tubes [From day of surgery to removal of chest tubes (up to 33 days)]

   Time to removal of chest tubes is the number of days from the time of chest tube placement to time they were removed.

5. Number of Participants With Allergic Reactions [Up to 28 days after surgery]

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

6. All-Cause Mortality [Up to 28 days after surgery]

   All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults aged 18 years or older undergoing elective thoracic surgery at Brigham & Women's Hospital. The majority of these patients will be undergoing lung resection for either the evaluation of a lung mass, or for the removal of a known malignancy. Some participants may be undergoing biopsy or removal of a mediastinal mass.

• Undergoing thoracic surgery procedure expected to require tube thoracostomy.

• Ability to give informed consent

Exclusion Criteria:

• Patients undergoing the following complex thoracic surgical procedures:

• Pneumonectomy

• Decortication

• Chemical pleurodesis

• Pleurectomy

• Lung volume reduction

• Esophagectomy

• Patients with the following conditions:

• Prior diagnosis of empyema or lung abscess.

• Cystic fibrosis

• Known or suspected pneumonia pre-operatively.

• Known hypersensitivity to beta-lactam antibiotics and vancomycin

• Current or recent antibiotic use within one week of surgery.

• Anticipated requirement for postoperative antibiotic in addition to 48 hours of cefazolin or vancomycin.

• Renal insufficiency with estimated creatinine clearance <60 ml/minute.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Lindsey Baden, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David A. Oxman, MD, Co-Investigator, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00818766
• Other Study ID Numbers: 2007p002164
• First Posted: Jan 8, 2009
• Last Update Posted: Apr 26, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by David A. Oxman, MD, Co-Investigator, Brigham and Women's Hospital: Thoracic Surgery; Antibiotic Prophylaxis; Chest Tube
• Additional relevant MeSH terms: Vancomycin; Cefazolin

Study Results

Participant Flow

Recruitment Details	Patients presenting for elective lung surgery and expected to require tube thoracostomy were approached for participation in the study at the time of preoperative evaluation.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Period Title: Overall Study
STARTED	125	126
Received Allocated Intervention	122	126
Intent-to-Treat Population	121	124
COMPLETED	110	116
NOT COMPLETED	15	10

Baseline Characteristics

Arm/Group Title	Antibiotic	Placebo	Total
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.	Total of all reporting groups
Overall Participants	121	124	245
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	63	62	62.5
Sex: Female, Male (Count of Participants)
Female	69 57%	70 56.5%	139 56.7%
Male	52 43%	54 43.5%	106 43.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced At Least One Postoperative Infectious Complication
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	13 10.7%	8 6.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Antibiotic, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.26
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-4.3
	Confidence Interval	() 95%; -11.3 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Participants Who Experienced Surgical Site Infection
Description	Surgical Site Infection: 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 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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	6 5%	5 4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Antibiotic, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95%; -6.1 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Number of Participants Who Experienced Pneumonia
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	7 5.8%	3 2.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Antibiotic, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.21
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-3.4
	Confidence Interval	(2-Sided) 95%; -8.3 to 1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Number of Participants Who Experienced Empyema
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	1 0.8%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Antibiotic, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.49
	Comments
	Method	Fisher Exact
	Comments

5. Primary Outcome

Title	Number of Participants Who Experienced Clostridium (C) Difficile Colitis
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery
Description	The number of participants who needed any additional non-study antibiotics for any reason after randomization.
Time Frame	Up to 28 days after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	32 26.4%	31 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Antibiotic, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.25
	Comments
	Method	Fisher Exact
	Comments

7. Secondary Outcome

Title	Number of Participants Who Needed Reoperation
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	5 4.1%	10 8.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Antibiotic, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.25
	Comments
	Method	Fisher Exact
	Comments

8. Secondary Outcome

Title	Length of Hospital Stay
Description	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Median (Full Range) [days]	3	3

9. Secondary Outcome

Title	Time to Removal of Chest Tubes
Description	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Median (Full Range) [days]	2	2

10. Secondary Outcome

Title	Number of Participants With Allergic Reactions
Description	The number of participants with an allergic reaction to a drug.
Time Frame	Up to 28 days after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	0 0%	0 0%

11. Secondary Outcome

Title	All-Cause Mortality
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Antibiotic	Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.	Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Measure Participants	121	124
Count of Participants [Participants]	1 0.8%	0 0%

Adverse Events

Time Frame	From the time immediately following surgery up to 28 days.
Arm/Group Title	Antibiotic		Placebo
Arm/Group Description	Cefazolin or vancomycin: 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.		Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
All Cause Mortality
	Antibiotic		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/121 (0.8%)		0/124 (0%)
Serious Adverse Events
	Antibiotic		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/121 (0.8%)		0/124 (0%)
Cardiac disorders
Atrial fibrillation	1/121 (0.8%)		0/124 (0%)
Other (Not Including Serious) Adverse Events
	Antibiotic		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/124 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.