The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

NCT01504568 | Withdrawn

• 1 other identifier: 134357
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Orbital Fractures; Orbital Cellulitis

Outcome Measures

Primary Outcomes (1)

• Orbital Cellulitis

  The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.

  Two weeks

Study Arms (2)

Prophylactic Antibotics

OTHER

Amoxicillin/clavulanic acid

Other: Treatment

Non Treatment

NO INTERVENTION

Subjects will be followed without the use of antibiotics.

Interventions

Treatment OTHER

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

Also known as: Amoxcillin/cavulanic acid

Prophylactic Antibotics

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated orbital blow out fracture in patients between the ages 5 to 99 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Orbital Fractures; Orbital Cellulitis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Orbital Diseases; Eye Diseases; Cellulitis; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 5, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

US (1)