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The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

This study has been withdrawn prior to enrollment.
(No subjects enrolled)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01504568
First received: January 3, 2012
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Orbital Fractures
Orbital Cellulitis
 Other: Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Orbital Cellulitis [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.


Enrollment: 0
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Prophylactic Antibotics
Amoxicillin/clavulanic acid
 Other: Treatment
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504568

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01504568     History of Changes
Other Study ID Numbers: 134357
Study First Received: January 3, 2012
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cellulitis
Fractures, Bone
Orbital Fractures
Orbital Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Wounds and Injuries
 Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Skull Fractures
Orbital Diseases
Eye Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013