Back to resultsThe Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Primary Purpose
Orbital Fractures, Orbital Cellulitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment
Sponsored by
About this trial
This is an interventional prevention trial for Orbital Fractures
Eligibility Criteria
Inclusion Criteria:
- Isolated orbital blow out fracture in patients between the ages 5 to 99 years old
Exclusion Criteria:
- Involvement of the orbital rim in the floor fracture requiring the use of antibiotics
- Involvement of the orbital rim in the floor fracture
- Radiographic evidence of occlusion of the maxillary sinus ostium
- Determined need for surgical intervention or prior use of synthetic implanted material in or around the involved maxillary sinus
- Any symptoms of sinonasal disease in the preceding 3 month for any reason
- Any use of oral or IV antibiotics in the preceding 3 month for any reason
- Documented allergy to penicillin or amoxicillin prohibiting its use
- Any currently immunosuppressed state, including actively treated autoimmune disease; use of steroids, immunomodulatory medication, or chemotherapy within the last year; diagnosis of active cancer within the last year
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Prophylactic Antibotics
Non Treatment
Arm Description
Amoxicillin/clavulanic acid
Subjects will be followed without the use of antibiotics.
Outcomes
Primary Outcome Measures
Orbital Cellulitis
The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.
Secondary Outcome Measures
Full Information
NCT ID
NCT01504568
First Posted
January 3, 2012
Last Updated
November 8, 2012
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT01504568
Brief Title
The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Official Title
The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects enrolled
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orbital Fractures, Orbital Cellulitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic Antibotics
Arm Type
Other
Arm Description
Amoxicillin/clavulanic acid
Arm Title
Non Treatment
Arm Type
No Intervention
Arm Description
Subjects will be followed without the use of antibiotics.
Intervention Type
Other
Intervention Name(s)
Treatment
Other Intervention Name(s)
Amoxcillin/cavulanic acid
Intervention Description
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
Primary Outcome Measure Information:
Title
Orbital Cellulitis
Description
The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated orbital blow out fracture in patients between the ages 5 to 99 years old
Exclusion Criteria:
Involvement of the orbital rim in the floor fracture requiring the use of antibiotics
Involvement of the orbital rim in the floor fracture
Radiographic evidence of occlusion of the maxillary sinus ostium
Determined need for surgical intervention or prior use of synthetic implanted material in or around the involved maxillary sinus
Any symptoms of sinonasal disease in the preceding 3 month for any reason
Any use of oral or IV antibiotics in the preceding 3 month for any reason
Documented allergy to penicillin or amoxicillin prohibiting its use
Any currently immunosuppressed state, including actively treated autoimmune disease; use of steroids, immunomodulatory medication, or chemotherapy within the last year; diagnosis of active cancer within the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Westfall, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Thuro, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Pemberton, D.O.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
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