Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax

This study has been completed.
Sponsor:
Information provided by:
St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier:
NCT01127880
First received: May 19, 2010
Last updated: May 20, 2010
Last verified: February 2009
  Purpose

The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.


Condition Intervention Phase
Hemopneumothorax
Pneumothorax
Drug: Ancef or Clindamycin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study

Resource links provided by NLM:


Further study details as provided by St. Luke's Hospital, Pennsylvania:

Primary Outcome Measures:
  • efficacy of prophylactic antibiotics in reduction of empyema [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The primary objective of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.


Secondary Outcome Measures:
  • Incidence of Pneumonia and/or development of resistant microorganisms [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Secondary objectives include:

    Incidence of pneumonia Incidence of development of resistant microorganisms



Enrollment: 50
Study Start Date: July 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ancef 1 gm or Clindamycin 300 mg
Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists
Drug: Ancef or Clindamycin
1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic
Placebo Comparator: Placebo
Group B will receive .9% Normal Saline as a placebo.
Drug: Placebo
.9% Normal Saline as a placebo

Detailed Description:

In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 16 years of age.
  2. Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
  3. Traumatic pneumothorax, hemothorax or hemopneumothorax

Exclusion Criteria:

  1. Pregnancy
  2. Open fracture
  3. Immunocompromised
  4. Require antibiotics for treatment of other injuries
  5. Chest tube placement greater than 72hrs after admission
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127880

Locations
United States, Pennsylvania
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania
Investigators
Principal Investigator: Nathaniel McQuay, MD St. Luke's Hospital and Health Network
  More Information

No publications provided

Responsible Party: Nathaniel McQuay, Jr., MD, St. Luke's Hospital and Health Network
ClinicalTrials.gov Identifier: NCT01127880     History of Changes
Other Study ID Numbers: SLHN 2005-34
Study First Received: May 19, 2010
Last Updated: May 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's Hospital, Pennsylvania:
Traumatic Hemopneumothorax
Thoracotomy
Antibiotics

Additional relevant MeSH terms:
Hemopneumothorax
Pneumothorax
Hemothorax
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes
Anti-Bacterial Agents
Cefazolin
Clindamycin
Clindamycin-2-phosphate
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014