Try our beta test site
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...

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
Results First Received: November 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Antibiotic Prophylaxis
Interventions: Drug: cefazolin or vancomycin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients presenting for elective lung surgery and expected to require tube thoracostomy were approached for participation in the study at the time of preoperative evaluation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Antibiotic 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
Placebo Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.

Participant Flow:   Overall Study
    Antibiotic   Placebo
STARTED   125   126 
Received Allocated Intervention   122 [1]   126 
Intent-to-Treat Population   121 [2]   124 [3] 
COMPLETED [4]   110   116 
NOT COMPLETED   15   10 
Could not be Contacted on Day 28                11                10 
Death                1                0 
Did not Receive Allocated Intervention                3                0 
[1] 1 withdrew consent, 1 had active infection and 1 was given open-label antibiotic after surgery.
[2] 1 participant was randomized twice but only counted once (per first randomization).
[3] 2 participants were randomized twice but only counted once (per first randomization).
[4] Completed = completed through 28-day follow-up phone call



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat (ITT) Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per their first randomization) in the ITT Population.

Reporting Groups
  Description
Antibiotic 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 cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
Placebo Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
Total Total of all reporting groups

Baseline Measures
   Antibiotic   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 121   124   245 
Age 
[Units: Years]
Median (Full Range)
 63 
 (24 to 85) 
 62 
 (26 to 84) 
 62.5 
 (24 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      69  57.0%      70  56.5%      139  56.7% 
Male      52  43.0%      54  43.5%      106  43.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Experienced At Least One Postoperative Infectious Complication   [ Time Frame: Up to 28 days after surgery ]

2.  Primary:   Number of Participants Who Experienced Surgical Site Infection   [ Time Frame: Up to 28 days after surgery ]

3.  Primary:   Number of Participants Who Experienced Pneumonia   [ Time Frame: Up to 28 days after surgery ]

4.  Primary:   Number of Participants Who Experienced Empyema   [ Time Frame: Up to 28 days after surgery ]

5.  Primary:   Number of Participants Who Experienced Clostridium (C) Difficile Colitis   [ Time Frame: Up to 28 days after surgery ]

6.  Secondary:   Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery   [ Time Frame: Up to 28 days after surgery ]

7.  Secondary:   Number of Participants Who Needed Reoperation   [ Time Frame: Up to 28 days after surgery ]

8.  Secondary:   Length of Hospital Stay   [ Time Frame: From day of surgery to discharge (up to 35 days) ]

9.  Secondary:   Time to Removal of Chest Tubes   [ Time Frame: From day of surgery to removal of chest tubes (up to 33 days) ]

10.  Secondary:   Number of Participants With Allergic Reactions   [ Time Frame: Up to 28 days after surgery ]

11.  Secondary:   All-Cause Mortality   [ Time Frame: Up to 28 days after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Oxman, MD
Organization: Brigham & Women's Hospital
phone: 215-503-1198
e-mail: doxman2001@yahoo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David A. Oxman, MD, 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