This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David A. Oxman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00818766
First received: January 7, 2009
Last updated: March 16, 2017
Last verified: March 2017
January 7, 2009
March 16, 2017
March 2008
April 2011   (Final data collection date for primary outcome measure)
  • 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
Primary Outcome Measures: Surgical site infection, pneumonia, empyema and clostridium difficile colitis. [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00818766 on ClinicalTrials.gov Archive Site
  • Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery [ Time Frame: Up to 28 days after surgery ]
    The number of participants who needed any additional non-study antibiotics for any reason after randomization.
  • Number of Participants Who Needed Reoperation [ Time Frame: 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.
  • Length of Hospital Stay [ Time Frame: 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.
  • Time to Removal of Chest Tubes [ Time Frame: 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.
  • Number of Participants With Allergic Reactions [ Time Frame: Up to 28 days after surgery ]
    The number of participants with an allergic reaction to a drug.
  • All-Cause Mortality [ Time Frame: Up to 28 days after surgery ]
    All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause.
Antibiotic escalation, need for re-operation, length of hospital stay and 30-day mortality. [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Antibiotic Prophylaxis
  • 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)
  • Drug: Placebo
    Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
  • 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.
    Intervention: Drug: cefazolin or vancomycin
  • 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.
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
April 2011
April 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00818766
2007p002164
No
Not Provided
Not Provided
David A. Oxman, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Lindsey Baden, MD Brigham and Women's Hospital
Brigham and Women's Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP