Placement of Antibiotic Powder in Open Fracture Wounds during the Emergency Room (POWDER): Design and Rationale for an Investigation of the Acute Application of Topical Antibiotic Powder in Open Fracture Wounds for Infection Prophylaxis.

Abstract

Background: Open fractures are at high risk for complications both in the military and civilian setting. Treatments to prevent fractures are limited in the Role 1 (prehospital, battalion aid station) setting. The goal of this study is to assess the efficacy of topical vancomycin powder, administered within 24 hours of an open fracture injury, in the prevention of infection and infection-related complications.

Methods: The POWDER study is a multicenter, prospective, randomized controlled clinical trial using a pragmatic open-label design. We will recruit 200 long bone open fracture patients from University Hospital at University of Texas Health at San Antonio (UTHSA) and the Brooke Army Medical Center (BAMC). We will screen and randomize patients in a 1:1 ratio to receive either usual care plus 2g topical vancomycin or usual care only. The primary objective of this study is to compare the proportion of infection and infection-related complications which occur in the 2 arms. An additional objective is to develop a risk-prediction model for open fracture wound complications.

Conclusions: The infection rates seen in open fractures remain alarmingly high in both combat and civilian settings. Several orthopedic surgery studies suggest vancomycin powder is effective in reducing surgical site infections when applied topically at the time of wound closure. We expect to see a reduction in infections in open fracture injuries treated acutely with vancomycin powder. This study may provide important information regarding the use of local vancomycin powder during the acute treatment of open fractures. If shown to be efficacious, vancomycin powder could provide a simple, time- and cost-effective infection prophylaxis strategy for these injuries.