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Completed

NCT Number: NCT00818766

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

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).

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Key information

Conditions

Antibiotic Prophylaxis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Cefazolin (Ancef), Vancomycin (Vancocin)

Placebo

Drug

Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.

Primary outcomes

  1. 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.

  2. Number of Participants Who Experienced Surgical Site Infection

    Time frame: 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

    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

  4. 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).

  5. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 8, 2009
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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