The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Not Applicable

Withdrawn

• Conditions: Orbital Fractures; Orbital Cellulitis
• Interventions: Other: Treatment

• Registration Number: NCT01504568
• Lead Sponsor: University of Arkansas

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.

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic Antibotics	Treatment	Amoxicillin/clavulanic acid

Primary Outcome Measures

Name	Time	Method
Orbital Cellulitis	Two weeks	The rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus not treated with prophylactic antibiotics.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States