Researchers to Test Osseointegration Infection-Reducing Product

Researchers at the University of Utah have selected an investigational antimicrobial wound dressing for testing as a way to reduce infections associated with prostheses, including osseointegrated implants.

The University of Utah, Brigham Young University, and Ceragenix Pharmaceuticals Inc., Denver, Colorado, announced January 29 that Ceragenix's Cerashield TM will be tested pursuant to grants received from the U.S. Department of Defense (DoD) and the Department of Veterans Affairs (VA), Research Rehabilitation and Development.

Cerashield is based on technology patented by Brigham Young University and exclusively licensed to Ceragenix. The technology is this year's winner of the Utah Innovation Award in the field of biotechnology and pharmaceuticals.

Traumatic, combat-related amputees have become a vital concern due to the number of young soldiers with limb amputations returning from the recent combat theaters in Iraq and Afghanistan. The ideal strategy for rehabilitating the amputee soldier to an active lifestyle is to develop skeletal implants that can be maintained without infection and attached to the human skeleton for the lifetime of the amputee, the announcement noted. However, in certain cases, bones are shattered so severely that conventional attachment procedures cannot be used. A new advance in artificial limb attachment--osseointegrated implants--overcomes this limitation and has been shown to allow the patients to have increased mobility, activity levels, gait performance, and oxygen consumption efficiency. Despite these potential clinical advantages, there are reports of serious complications with this approach including a 45-percent infection rate, the announcement noted.

Researchers at the University of Utah Bone and Joint Research Lab believe that the infection-related limitations of current osseointegrated implants can be addressed through use of a novel infection prevention agent. The University of Utah and the Department of Veterans Affairs have obtained $3.9 million in funding from the U.S. Department of Defense and VA Research Rehabilitation & Development to research new approaches to help reduce infection rates to allow widespread use of osseointegrated implants.

"We have evaluated a dozen different compounds and products for their antimicrobial properties, including several silver-based approaches, and have selected Cerashield based on our assessment of its excellent activity against multidrug-resistant bacteria as the product we wish to evaluate under our grants," said Roy Bloebaum, PhD, research professor and co-director of the University of Utah's Department of Orthopaedics Bone and Joint Research Lab and lead researcher on the project.

"We are honored to have been chosen to participate in this research, and we are gratified that our technology may be of benefit to those young men and women who have sacrificed so much for our country," said Steven Porter, chairman and CEO of Ceragenix Pharmaceuticals.

Cerashield is intended to be used as an antimicrobial wound dressing to help prevent bacterial colonization and infection at the site of catheter and other indwelling medical device insertions into the body, according to Ceragenix. Cerashield is a highly absorbent foam dressing that contains a novel antimicrobial agent, known as either CSA or Ceragenins TM , the company explained. Ceragenins are synthesized aminosterol compounds that mimic or exceed the antimicrobial activity of the naturally occurring antimicrobial peptides that form part of the human body's innate immune system.

Infections from a wide variety of implanted medical devices are a major health concern as nearly two million Americans acquired an infection while in the hospital, and 90,000 died from such infections. It is estimated that in about 70 percent of such hospital-acquired infections, the infection is linked to the presence of an indwelling medical device such as a central venous catheter. Infections arise because human beings carry bacteria on the surface of their skin which are ordinarily harmless but which may grow and cause infections when in the presence of a foreign object such as a medical device. Cerashield is intended to work by killing the bacteria on the surface of the skin surrounding the medical device to reduce the risk of infection, according to Ceragenix.

For more information about Ceragenix, visit www.ceragenix.com

For more information about infection solutions in relation to osseointegration, see the article, "Osseointegration: Infection Solutions" in the February 2007 issue of The O&P EDGE or visit www.oandp.com/edge/issues/articles/2007-02_01.asp

For more information about osseointegration, see the article, "Osseointegration: In the Wave of the Future?" in the September 2006 issue of The O&P EDGE or visit www.oandp.com/edge/issues/articles/2006-09_03.asp

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