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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | Participants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefazolin or vancomycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days after surgery |
| Number of Participants Who Experienced Surgical Site Infection | Surgical Site Infection:
| 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:
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days after surgery |
| Number of Participants Who Needed Reoperation |
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Inclusion Criteria:
Exclusion Criteria:
Patients undergoing the following complex thoracic surgical procedures:
Patients with the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Baden, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23325435 | Derived | Oxman DA, Issa NC, Marty FM, Patel A, Panizales CZ, Johnson NN, Licona JH, McKenna SS, Frendl G, Mentzer SJ, Jaklitsch MT, Bueno R, Colson Y, Swanson SJ, Sugarbaker DJ, Baden LR. Postoperative antibacterial 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. JAMA Surg. 2013 May;148(5):440-6. doi: 10.1001/jamasurg.2013.1372. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotic | 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. |
| FG001 | Placebo | Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The 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 their first randomization) in the ITT Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotic | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
From the time immediately following surgery up to 28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotic | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Oxman, MD | Brigham & Women's Hospital | 215-503-1198 | doxman2001@yahoo.com |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
|
| Placebo | Drug | Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first. |
|
| Up to 28 days after surgery |
| 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:
| 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. |
| 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. | 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. | 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. | 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. | Up to 28 days after surgery |
| Did not Receive Allocated Intervention |
|
| BG001 | Placebo | Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first. |
|
|
|
| Primary | Number of Participants Who Experienced Surgical Site Infection | Surgical Site Infection:
| 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
|
| Primary | Number of Participants Who Experienced Pneumonia | Pneumonia: A new infiltrate on chest x-ray associated with at least three of the following:
| 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
|
| Primary | Number of Participants Who Experienced Empyema | Empyema: Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (>38°C). | 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
|
| Primary | 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:
| 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
|
| Secondary | Length of Hospital Stay | The length of hospital stay is the number of days the participant remained in the hospital. | 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. | Posted | Median | Full Range | days | From day of surgery to discharge (up to 35 days) |
|
|
|
| Secondary | 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. | 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. | Posted | Median | Full Range | days | From day of surgery to removal of chest tubes (up to 33 days) |
|
|
|
| Secondary | Number of Participants With Allergic Reactions | The number of participants with an allergic reaction to a drug. | 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
| Secondary | All-Cause Mortality | All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause. | 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. | Posted | Count of Participants | Participants | Up to 28 days after surgery |
|
|
|
| 1 |
| 121 |
| 1 |
| 121 |
| 0 |
| 121 |
| EG001 | Placebo | Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first. | 0 | 124 | 0 | 124 | 0 | 124 |
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| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |