With studies showing that patients requiring orthopedic surgery may be three times more likely to experience post-operative infections than patients undergoing other forms of surgery, the Perelman School of Medicine at the University of Pennsylvania has accepted a $2.5 million grant for a study. The grant is from the Congressionally Directed Medical Research Program (CDMRP) and will be used to begin Phase II human trials of the effectiveness of treating post-surgical orthopedic infections with Microbion Corporation’s topical BisEDT drug. Phase 1 human trials of BisEDT were successfully completed in 2011. Clinical studies for Phase 2 will begin in 2013 at the Hospital of the University of Pennsylvania, and at UCSF/San Francisco General Hospital.
Infection Fighting Gel Tested
“We’re honored to be given this award from the Department of Defense (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, ” says Samir Mehta, M.D., chief of the Orthopedic Trauma and Fracture Service at Perelman. “Orthopedic 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.”
“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, Ph.D., director of Clinical Research for Penn Orthopedics. “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.”
Orthopedic extremity injuries also constitute the majority (65%) 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%.
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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