Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax
The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedMay 21, 2010
February 1, 2009
4.4 years
May 19, 2010
May 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (1)
Incidence of Pneumonia and/or development of resistant microorganisms
30 days
Study Arms (2)
Ancef 1 gm or Clindamycin 300 mg
ACTIVE COMPARATORGroup A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists
Placebo
PLACEBO COMPARATORGroup B will receive .9% Normal Saline as a placebo.
Interventions
1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic
Eligibility Criteria
You may qualify if:
- Age ≥ 16 years of age.
- Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
- Traumatic pneumothorax, hemothorax or hemopneumothorax
You may not qualify if:
- Pregnancy
- Open fracture
- Immunocompromised
- Require antibiotics for treatment of other injuries
- Chest tube placement greater than 72hrs after admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathaniel McQuay, MD
St. Luke's Hospital and Health Network
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 21, 2010
Study Start
July 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 21, 2010
Record last verified: 2009-02