Back to resultsRole of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax
Primary Purpose
Hemopneumothorax, Pneumothorax
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ancef or Clindamycin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hemopneumothorax focused on measuring Traumatic Hemopneumothorax, Thoracotomy, Antibiotics
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 16 years of age.
- Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
- Traumatic pneumothorax, hemothorax or hemopneumothorax
Exclusion Criteria:
- Pregnancy
- Open fracture
- Immunocompromised
- Require antibiotics for treatment of other injuries
- Chest tube placement greater than 72hrs after admission
Sites / Locations
- St. Luke's Hospital and Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ancef 1 gm or Clindamycin 300 mg
Placebo
Arm Description
Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists
Group B will receive .9% Normal Saline as a placebo.
Outcomes
Primary Outcome Measures
efficacy of prophylactic antibiotics in reduction of empyema
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
Secondary objectives include:
Incidence of pneumonia Incidence of development of resistant microorganisms
Full Information
NCT ID
NCT01127880
First Posted
May 19, 2010
Last Updated
May 20, 2010
Sponsor
St. Luke's Hospital, Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01127880
Brief Title
Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax
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 Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St. Luke's Hospital, Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemopneumothorax, Pneumothorax
Keywords
Traumatic Hemopneumothorax, Thoracotomy, Antibiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ancef 1 gm or Clindamycin 300 mg
Arm Type
Active Comparator
Arm Description
Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group B will receive .9% Normal Saline as a placebo.
Intervention Type
Drug
Intervention Name(s)
Ancef or Clindamycin
Intervention Description
1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
.9% Normal Saline as a placebo
Primary Outcome Measure Information:
Title
efficacy of prophylactic antibiotics in reduction of empyema
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of Pneumonia and/or development of resistant microorganisms
Description
Secondary objectives include:
Incidence of pneumonia Incidence of development of resistant microorganisms
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 16 years of age.
Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
Traumatic pneumothorax, hemothorax or hemopneumothorax
Exclusion Criteria:
Pregnancy
Open fracture
Immunocompromised
Require antibiotics for treatment of other injuries
Chest tube placement greater than 72hrs after admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel McQuay, MD
Organizational Affiliation
St. Luke's Hospital and Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Hospital and Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax
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