Healthcare Industry News: ETHICON
News Release - February 13, 2007
FDA-approved Ostene, Made by Ceremed Inc. and Designed for Use in Cardiac Surgery, May Reduce Serious Post-operative Complications in Heart Patients
LOS ANGELES, Feb. 13 (HSMN NewsFeed) -- New animal studies show that Ostene reduces the risk of infection and improves healing of the sternum when used as a substitute for bone wax to stop bleeding in heart surgery. Scientists looked at the two materials' effect on the bone's susceptibility to infection in the presence of Staphylococcus bacteria, a version of which is responsible for hospital-acquired antibiotic resistant infections. The infection rate for bone wax-treated bones was 100%. By contrast, only 25% of bones with Ostene developed infections -- the same rate as bones in the control group without any foreign body in them. The results of the study were submitted to the FDA.In a separate study to be announced at the upcoming annual meeting of the American Association for Thoracic Surgery (AATS) in Washington D.C., scientists at the Medical University of South Carolina compared the effect of Ostene and bone wax on the bone healing and strength of the sternum in rabbits following median sternotomy -- a procedure with which most cardiac surgeries begin. The results showed that the sternums treated with Ostene heal significantly faster and their mechanical strength is double that of the sternums treated with bone wax.
Ostene is a sterile mixture of water-soluble alkylene oxide copolymers developed as an affordable, long-overdue synthetic alternative to bone wax, a beeswax-based remedy used to stop bone bleeding since the Civil War. Ostene looks and feels like bone wax -- without its side effects. Unlike bone wax, it dissolves and is eliminated from the body unchanged shortly after surgery. Ostene was invented and patented by scientists from the University of Southern California. They teamed up with Dr. Tadeusz Wellisz, a USC clinical professor of surgery with experience in developing and marketing medical products, and gained the FDA approval for Ostene last year.
Bone wax is the least expensive and most common bone hemostasis material used in the operating room -- bone wax maker and distributor Johnson & Johnson's ETHICON sold several million applications in 2006. A subject of numerous studies, bone wax is known to inhibit bone growth and bone healing after surgery: Once covered with bone wax, a bone does not regenerate -- a major problem for a cardiac surgery patient hoping for his cut sternum to heal well. Unlike Ostene, bone wax remains at the surgical site indefinitely and increases the risk of post-operative infections by interfering with the body's ability to clear bacteria and reducing 10,000 fold the amount of bacteria needed to cause an infection.
Sternal wound infection following cardiac surgery is a serious and often lethal complication, as is the separation of the sternum caused by the sternum's failure to heal, which occurs in up to 5% of patients (that is one out of twenty patients). The results of infection and sternal strength studies suggest that the use of Ostene as a substitute for bone wax in cardiac surgery may help reduce the instances of both complications and may also have implications for lowering the risk of hospital-acquired infections, including MRSA. The benefits of Ostene may be particularly significant for a growing high-risk group of diabetics and overweighed patients who currently represent 25% of the 2,000,000 cardiac surgery cases in the world's most developed countries.
"I've spent 15 years in reconstructive surgery taking care of people with bone wax infections," says Ostene maker Ceremed Inc.'s CEO Dr. Tadeusz Wellisz. "I had a near-tragedy in my own family that can be directly attributed to the use of beeswax-based bone wax. When I learned of an alternative, I knew that bringing it into clinical use was something I had to do. With the current emergence of antibiotic-resistant bacteria, we absolutely have to do all we can to reduce the risk of hospital-acquired infections."
For more information, please visit http://www.ceremed.com
Source: Ceremed
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