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

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ClinicalTrials.gov Identifier: NCT01127880
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : May 21, 2010
Sponsor:
Information provided by:
St. Luke's Hospital, Pennsylvania

Brief Summary:
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 or disease Intervention/treatment Phase
Hemopneumothorax Pneumothorax Drug: Ancef or Clindamycin Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. efficacy of prophylactic antibiotics in reduction of empyema [ Time Frame: 30 days ]
    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 :
  1. Incidence of Pneumonia and/or development of resistant microorganisms [ Time Frame: 30 days ]

    Secondary objectives include:

    Incidence of pneumonia Incidence of development of resistant microorganisms




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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: May 21, 2010
Last Verified: February 2009

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

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