The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01504568|
Recruitment Status : Withdrawn (No subjects enrolled)
First Posted : January 5, 2012
Last Update Posted : November 9, 2012
The purpose of the research is to perform a quality assurance evaluation using randomized prospective analysis the rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.
The investigators goal is to show the use of prophylactic antibiotics in orbital blowout fractures does not significantly decrease the rate of orbital cellulitis and is thus not indicated.
|Condition or disease||Intervention/treatment||Phase|
|Orbital Fractures Orbital Cellulitis||Other: Treatment||Not Applicable|
Orbital fractures are a common occurrence in association with a wide variety of blunt trauma injuries to the face. One type of fracture is that involving the orbital floor, or an isolated blowout fracture. One common current practice is to use prophylactic antibiotics in these cases to prevent the theoretical occurrence of an orbital cellulitis originating from sinus flora, though there is no current standard of care regarding this practice. Many surgeons may elect to not use antibiotics for this very reason.
The use of prophylactic antibiotics in isolated blowout fractures where there is no occlusion of the ostium is not defined, and no prospective controlled study has been undertaken to suggest the most appropriate course of action to take. Our goal in this study is to determine a correct course of action for these patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Prophylactic Antibiotics in Isolated Blowout Fractures|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Adults: ≥40 kg:250mg every eight hours Children: <40kg: 20mg/kg/day divided in three doses (up to 250mg) every eight hours Suspension form 250mg/ml
Other Name: Amoxcillin/cavulanic acid
No Intervention: Non Treatment
Subjects will be followed without the use of antibiotics.
- Orbital Cellulitis [ Time Frame: Two weeks ]The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.
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): NCT01504568
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Christopher Westfall, M.D.||University of Arkansas|
|Principal Investigator:||Bradley Thuro, M.D.||University of Arkansas|
|Principal Investigator:||John Pemberton, D.O.||University of Arkansas|