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

Not Applicable

Completed

Conditions: Antibiotic Prophylaxis

Interventions: Drug: cefazolin or vancomycin
Drug: Placebo

Registration Number: NCT00818766

Lead Sponsor: Brigham and Women's Hospital

Brief 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 251

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic	cefazolin or vancomycin	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	Participants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced At Least One Postoperative Infectious Complication	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	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	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	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	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

Name	Time	Method
Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery	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	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	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	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	Up to 28 days after surgery	The number of participants with an allergic reaction to a drug.
All-Cause Mortality	Up to 28 days after surgery	All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause.