PHILADELPHIA — A team of researchers led by Samir Mehta, MD, chief of the Orthopaedic Trauma & Fracture Service at the Perelman School of Medicine at the University of Pennsylvania, has received a $2.5 million grant from the Congressionally Directed Medical Research Program (CDMRP), provided through the U.S. Department of Defense (DoD), to begin Phase 2 human trials of a study that examines the effective treatment of post-surgical orthopedic infections using Microbion Corporation’s topical BisEDT drug. The University of Pennsylvania will work with a team of researchers from Microbion and the University of California-San Francisco on the trial, set to begin pending FDA approval.
“We’re honored to be given this award from the DoD, and are hopeful that the Phase 2 trial will allow us to offer improved treatments and standards of care to a significant number of patients,” said Mehta. “Orthopaedic trauma and fracture patients are at an increased risk for infection. If successful, this new treatment strategy could be a significant step toward reducing instances of amputation, disability, and even death.”
Studies show that patients requiring orthopaedic trauma surgery may be three times more likely to experience post-operative infections (8.7 percent) than patients undergoing other forms of surgery (2.8 percent) as a result of the high-energy nature of the injury. With approximately 2.6 million orthopaedic devices implanted annually in the United States, approximately 4.3 percent (112,000 patients) will suffer from a post-operative infection.
Orthopaedic extremity injuries also constitute the majority (65 percent) of combat casualties experienced in recent U.S. military conflicts. The risk of infection developing after surgical treatment of traumatic, open military wounds represents an extremely serious threat; reports indicate that military wound infection rates may be as high as 77 percent. Such infections frequently lead to death, amputation, disability, and other significant morbidity, despite the best available care.
“The goal of our study is to examine the efficacy and safety of administering a single application of Microbion’s topical BisEDT gel to infected extremity wounds,” said Annamarie Horan, MPA, PhD, director of Clinical Research for Penn Orthopaedics. “The gel is not a replacement for standard antibiotics, but the promising results of the Phase 1 trial provide strong evidence suggesting the drug may be an effective supplemental treatment.”
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