The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Orbital Fractures Clinical Trial

Official title: The Use of Prophylactic Antibiotics in Isolated Blowout Fractures

Status Withdrawn

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.

Clinical Trial 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 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

• NCT number: NCT01504568
• Study type: Interventional
• Source: University of Arkansas
• Status: Withdrawn
• Phase: N/A
• Start date: January 2012
• Completion date: November 2012