Antibiotic ProphylaxisNCT00818766
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy
A study testing cefazolin or vancomycin in people with Antibiotic Prophylaxis, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Prophylaxis
- What is being tested?
- cefazolin or vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients undergoing the following complex thoracic surgical procedures:
- Pneumonectomy
- Decortication
- Chemical pleurodesis
- Pleurectomy
- Lung volume reduction
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
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
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).
Read the 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.
- Conditions
- Antibiotic Prophylaxis
- Being tested
- cefazolin or vancomycin, Placebo
- Keywords
- Thoracic Surgery, Antibiotic Prophylaxis, Chest Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefazolin or vancomycinDrug
Also called Cefazolin (Ancef), Vancomycin (Vancocin)
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.
PlaceboDrug
Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: cefazolin or vancomycin |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days after surgery
Number of Participants Who Experienced Surgical Site Infection
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
Measured: 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
Measured: 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).
Measured: Up to 28 days after surgery
Number of Participants Who Experienced Clostridium (C) Difficile Colitis
- 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
Measured: Up to 28 days after surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Oxman, MD, Brigham and Women's Hospital
- Investigators
- Lindsey Baden, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818766
- Sponsor's protocol ID
- 2007p002164
- Status last verified
- Mar 2017
- First submitted
- 7 Jan 2009
- Last updated
- 26 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23325435
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00818766
- Acronym / sponsor ID
- 2007p002164
- Conditions
- Antibiotic Prophylaxis
- Keywords
- Thoracic Surgery, Antibiotic Prophylaxis, Chest Tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Posted 26 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic | Active comparator | Drug: cefazolin or vancomycinParticipants 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 | Drug: PlaceboParticipants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- Patients undergoing the following complex thoracic surgical procedures:
- Patients with the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefazolin or vancomycinAlso: Cefazolin (Ancef), Vancomycin (Vancocin)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. | Drug | Antibiotic |
| PlaceboParticipants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first. | Drug | Placebo |
Primary outcome
Number of Participants Who Experienced At Least One Postoperative Infectious Complication
Time frame: 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.
Number of Participants Who Experienced Surgical Site Infection
Time frame: Up to 28 days after surgery
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
Number of Participants Who Experienced Pneumonia
Time frame: 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
Number of Participants Who Experienced Empyema
Time frame: Up to 28 days after surgery
Empyema: Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (>38°C).
Number of Participants Who Experienced Clostridium (C) Difficile Colitis
Time frame: 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
6 secondary outcomes
Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery
Time frame: Up to 28 days after surgery
Number of Participants Who Needed Reoperation
Time frame: Up to 28 days after surgery
Length of Hospital Stay
Time frame: From day of surgery to discharge (up to 35 days)
Time to Removal of Chest Tubes
Time frame: From day of surgery to removal of chest tubes (up to 33 days)
Number of Participants With Allergic Reactions
Time frame: Up to 28 days after surgery
All-Cause Mortality
Time frame: Up to 28 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23325435Oxman 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Baden, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cefazolin or vancomycin in people with Antibiotic Prophylaxis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced At Least One Postoperative Infectious Complication (time frame: Up to 28 days after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.