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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01504568 |
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Date of registration:
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03/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
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Scientific title:
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The Use of Prophylactic Antibiotics in Isolated Blowout Fractures |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01504568 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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John Pemberton, D.O. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Arkansas |
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Name:
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Bradley Thuro, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Arkansas |
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Name:
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Christopher Westfall, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Arkansas |
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Key inclusion & exclusion criteria
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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
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Orbital Fractures
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Orbital Cellulitis
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Intervention(s)
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Other: Treatment
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Primary Outcome(s)
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Orbital Cellulitis
[Time Frame: Two weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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