A New UCLA study shows Ceremed Inc.'s Ostene, designed to stop bone bleeding during cardiac surgery, doesn't inhibit bone regeneration and is an effective substitute for commonly used bone wax, a beeswax-based remedy known to obstruct healing that has been in use at least since the Civil War and is a factor in hospital-acquired infections. The study results were announced at a scientific conference in Stockholm and will be published later this year.
Scientists at the University of California, Los Angeles compared the effect of Ostene and beeswax on the bone healing in rats. The results show that while the two materials are equally effective in stopping bone bleeding in surgery, the bone heals significantly quicker when treated with Ostene. "The signs of healing were visible as early as three weeks after surgery in the group treated with Ostene, while they were practically absent as late as twelve weeks after treatment in the beeswax group. That's a significant difference", says Ceremed's Senior Scientific Officer Jon Armstrong. Beeswax is currently the most widely used bone hemostasis material.
The UCLA study concluded that, unlike beeswax, Ostene does not inhibit bone healing and bone regeneration. The use of Ostene in cardiac surgery may therefore help reduce the risk of post-operative separation of the sternum — a serious and potentially lethal complication which affects one out of twenty cardiac surgery patients and is the result of the cut bone's failure to heal and hold together.
Ostene was invented as a long-overdue synthetic alternative to beeswax by scientists from the University of Southern California. They teamed up with Dr. Tad Wellisz, a USC clinical professor of surgery with experience in developing and marketing medical products, and gained FDA approval for Ostene last year. "I've spent 15 years in reconstructive surgery taking care of people with beeswax infections. I had a near-tragedy in my own family that can be directly attributed to the use of beeswax. When I learned of an alternative, I knew that bringing it into clinical use was something I had to do", explains Ceremed's CEO Dr. Tad Wellisz. "With the current emergence of antibiotic-resistant bacteria, we absolutely have to do all we can to reduce the risk of hospital-acquired infections."
Research supports Dr. Wellisz's experience with beeswax. Beeswax increases the risk of infection, causes inflammation, swelling and debilitating pain. It is a factor in hospital-acquired antibiotic-resistant infections — according to a study in the Journal of Thoracic and Cardiovascular Surgery, the presence of beeswax reduces the number of bacteria needed to produce a bone infection by a factor of 10,000. Another study, published in the April 2006 issue of the journal Pathology, demonstrates that beeswax remains at the surgical site indefinitely and may induce an inflammatory response even 10 years after surgery. It also prevents new bone formation and bone union. Once covered with beeswax, a bone does not regenerate — a major problem for a cardiac surgery patient hoping for his cut sternum to heal well.
Water-soluble and completely synthetic in origin, Ostene doesn't increase the risk of infection. It allows the bone to heal without causing an inflammatory response. Unlike beeswax, it is eliminated from the body shortly after surgery and doesn't react with the body's chemistry.