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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
  Purpose
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 Intervention
Antibiotic Prophylaxis Drug: cefazolin or vancomycin Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by David A. Oxman, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 251
Study Start Date: March 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818766

Locations
United States, Massachusetts
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David A. Oxman, MD, Co-Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00818766     History of Changes
Other Study ID Numbers: 2007p002164
Study First Received: January 7, 2009
Results First Received: November 23, 2016
Last Updated: March 16, 2017

Keywords provided by David A. Oxman, MD, Brigham and Women's Hospital:
Thoracic Surgery
Antibiotic Prophylaxis
Chest Tube

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Vancomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on June 23, 2017