Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-04 @ 4:54 AM
Study NCT ID:
NCT01504568
Status:
WITHDRAWN
Last Update Posted:
2012-11-09
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009917', 'term': 'Orbital Fractures'}, {'id': 'D054517', 'term': 'Orbital Cellulitis'}], 'ancestors': [{'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-08', 'studyFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2012-01-04', 'lastUpdatePostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orbital Cellulitis', 'timeFrame': 'Two weeks', 'description': 'The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orbital Fractures', 'Orbital Cellulitis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated orbital blow out fracture in patients between the ages 5 to 99 years old\n\nExclusion Criteria:\n\n* Involvement of the orbital rim in the floor fracture requiring the use of antibiotics\n* Involvement of the orbital rim in the floor fracture\n* Radiographic evidence of occlusion of the maxillary sinus ostium\n* Determined need for surgical intervention or prior use of synthetic implanted material in or around the involved maxillary sinus\n* Any symptoms of sinonasal disease in the preceding 3 month for any reason\n* Any use of oral or IV antibiotics in the preceding 3 month for any reason\n* Documented allergy to penicillin or amoxicillin prohibiting its use\n* 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'}, 'identificationModule': {'nctId': 'NCT01504568', 'briefTitle': 'The Use of Prophylactic Antibiotics in Isolated Blowout Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'The Use of Prophylactic Antibiotics in Isolated Blowout Fractures', 'orgStudyIdInfo': {'id': '134357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Prophylactic Antibotics', 'description': 'Amoxicillin/clavulanic acid', 'interventionNames': ['Other: Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Non Treatment', 'description': 'Subjects will be followed without the use of antibiotics.'}], 'interventions': [{'name': 'Treatment', 'type': 'OTHER', 'otherNames': ['Amoxcillin/cavulanic acid'], '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', 'armGroupLabels': ['Prophylactic Antibotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Christopher Westfall, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}, {'name': 'Bradley Thuro, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}, {'name': 'John Pemberton, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}