Vancomycin Powder for Acute, Long-Bone, Open-Fracture Infection Prophylaxis: a Multicenter, Randomized, Controlled Trial
Abstract
The proposed clinical study will address the fiscal year 2017 Peer Reviewed Orthopaedic Research Program Focus Area of optimizing patient outcomes after extremity fractures. Over a 1-year period, we will test the efficacy of a powder form of the antibiotic, vancomycin, applied directly into traumatic open-fracture wounds of the arm or leg in the Emergency Department (ED) before surgery to repair the fracture, for the purpose of reducing wound infections and associated health complications. The nature of military combat operations exposes Service members to a high risk of fractures with open wounds, which can become contaminated from soil, weapon fragments, shrapnel, and debris, all of which increase the likelihood of infection. Development of infection in combat wounds is associated with serious downstream health consequences, including rehospitalization and death. Preventing infections in battlefield and non-battlefield extremity open fractures may reduce the risk of long-term, infection-related complications, as well as the need for additional treatments and procedures that prolong recovery time, impact unit readiness, and delay return to duty. The high complication rates associated with extremity injuries, particularly those related to wound infection, significantly increase healthcare utilization and costs. The current approach to preventing open-fracture infections is intravenous (IV) antibiotics, given as early after the injury as possible. On the battlefield, treatment with IV antibiotics can be challenging, and treatment can be significantly delayed. In contrast, topical antibiotics applied directly to the site of injury can be administered easily and quickly. Vancomycin powder is a Food and Drug Administration (FDA)-approved topical antibiotic that is available in a low-cost generic form. It requires no refrigeration and is lightweight and compact. It can be easily added to a medic’s aid bag and carried far forward into the battle space, where it can be administered quickly to reduce the risk of infection. Studies of the use of vancomycin powder applied during surgery of the spine have reported no adverse events. Few studies have investigated the benefits of vancomycin powder administered in the pre-hospital or ED setting on infection outcomes for open fractures of the extremities. As it is impractical to conduct a trial of vancomycin powder for reducing the infection complications of open-fracture wounds in the combat setting, we plan to conduct a trial in the ED setting, with the goal of producing results that can be extrapolated to the battlefield. The study will include adult patients with open fractures of the arm or leg who are being treated in the EDs of the San Antonio Military Medical Center (SAMMC) and the University of Texas Health Sciences Center at San Antonio (UTHSCSA). These two hospitals are the regional receiving centers for all trauma transfers within the Southern Texas Regional Advisory Council, which spans 22 counties. San Antonio is home to a large population of active-duty military personnel and Veterans who seek care at SAMMC and UTHSCSA, as well as the location of several industries that have an inherent risk of trauma-induced open-fracture injuries, including ranching, farming, and oil and gas exploration. Patients with open-fracture wounds of the arm or leg will receive either the usual care alone or the usual care plus application of vancomycin powder in the ED, before undergoing surgery to repair the fracture. We will then follow up with patients over a 1-year period to determine the need for additional surgery or medical treatments for infections of the fracture site, or the need for repeat clinical visits or hospitalizations for complications caused by infections. We expect to find that patients with an open extremity fracture who receive vancomycin powder in addition to the usual care in the ED will have a lower risk of developing infection or infection-relat
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1820074
Entities
People
- Robert Delorenzo
Organizations
- United States Army
- University of Texas Health Science Center at San Antonio