Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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|
- 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:
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
- Number of Participants Who Experienced Pneumonia [ Time Frame: Up to 28 days after surgery ]
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 ]
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
- 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.
|Study Start Date:||March 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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.
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.
Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818766
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lindsey Baden, MD||Brigham and Women's Hospital|