The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Orbital Fractures Clinical Trial

Official title:

The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01504568
• Other study ID #: 134357
• Status: Withdrawn
• Phase: N/A
• First received: January 3, 2012
• Last updated: November 8, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cellulitis
• Fractures, Bone
• Orbital Cellulitis
• Orbital Fractures

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No