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

NCT00818766 | Completed Results

• 1 other identifier: 2007p002164
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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).

Conditions

Antibiotic Prophylaxis

Keywords

Thoracic Surgery; Antibiotic Prophylaxis; Chest Tube

Outcome Measures

Primary Outcomes (5)

• Number of Participants Who Experienced At Least One Postoperative Infectious Complication

  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.

  Up to 28 days after surgery

• Number of Participants Who Experienced Surgical Site Infection

  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

  Up to 28 days after surgery

• Number of Participants Who Experienced Pneumonia

  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

  Up to 28 days after surgery

• Number of Participants Who Experienced Empyema

  Empyema: Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (\>38°C).

  Up to 28 days after surgery

• Number of Participants Who Experienced Clostridium (C) Difficile Colitis

  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

  Up to 28 days after surgery

Secondary Outcomes (6)

• Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery

  Up to 28 days after surgery

• Number of Participants Who Needed Reoperation

  Up to 28 days after surgery

• Length of Hospital Stay

  From day of surgery to discharge (up to 35 days)

• Time to Removal of Chest Tubes

  From day of surgery to removal of chest tubes (up to 33 days)

• Number of Participants With Allergic Reactions

  Up to 28 days after surgery

Study Arms (2)

Antibiotic

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Also known as: Cefazolin (Ancef), Vancomycin (Vancocin)

Antibiotic

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Oxman DA, Issa NC, Marty FM, Patel A, Panizales CZ, Johnson NN, Licona JH, McKenna SS, Frendl G, Mentzer SJ, Jaklitsch MT, Bueno R, Colson Y, Swanson SJ, Sugarbaker DJ, Baden LR. Postoperative antibacterial 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. JAMA Surg. 2013 May;148(5):440-6. doi: 10.1001/jamasurg.2013.1372.

  PMID: 23325435 DERIVED

MeSH Terms

Interventions

Cefazolin; Vancomycin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: David Oxman, MD
• Organization: Brigham & Women's Hospital

doxman2001@yahoo.com

215-503-1198

Study Officials

• Lindsey Baden, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: March 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-03

Locations

US (1)