N/A
N=251
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy
Antibiotic Prophylaxis
Bottom Line
View on ClinicalTrials.gov: NCT00818766 ↗Enrolled (actual)
251
Serious AEs
0.4%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants Who Experienced At Least One Postoperative Infectious Complication — 13; 8 Participants — p=.26
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cefazolin or vancomycin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced At Least One Postoperative Infectious Complication |
13; 8 | .26 |
| PRIMARY Number of Participants Who Experienced Surgical Site Infection |
6; 5 | 0.77 |
| PRIMARY Number of Participants Who Experienced Pneumonia |
7; 3 | .21 |
| PRIMARY Number of Participants Who Experienced Empyema |
1; 0 | .49 |
| PRIMARY Number of Participants Who Experienced Clostridium (C) Difficile Colitis |
0; 0 | — |
| SECONDARY Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery |
32; 31 | .25 |
| SECONDARY Number of Participants Who Needed Reoperation |
5; 10 | .25 |
| SECONDARY Length of Hospital Stay |
3; 3 | — |
| SECONDARY Time to Removal of Chest Tubes |
2; 2 | — |
| SECONDARY Number of Participants With Allergic Reactions |
0; 0 | — |
| SECONDARY All-Cause Mortality |
1; 0 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00818766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.