New FDA-Approved Treatment for Bone Bleeding Offers Alternative to Civil War-Era Remedy

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New Study shows Ceremed Inc.'s OsteneTM designed to stop bone bleeding in cardiac, orthopedic and neurospinal surgery offers healing benefits without harmful side effects associated with commonly used beeswax.

Almost 150 years after the battle of Gettysburg, surgeons still stop bones from bleeding the same way Civil War field doctors did in 1863 – using beeswax. That’s about to change.

A study just published in The Journal of Craniofacial Surgery shows a new synthetic copolymer called OsteneTM stops bone bleeding instantaneously, but unlike beeswax, it does so without interfering with bone healing or causing inflammation of the surrounding soft tissue.

Chemists from the University of Southern California have developed water-soluble OsteneTM as a long-overdue alternative to the old battlefield remedy. They teamed up with Dr. Tad Wellisz, a USC clinical professor of surgery with experience in developing and marketing medical products, and gained approval for OsteneTM from the Food and Drug Administration in 2005. Now OsteneTM, manufactured by Los Angeles-based Ceremed, Inc., can be used in U.S. operating rooms.

It’s high time. Beeswax, better known as bone wax, increases the risk of infection and causes allergic reactions, chronic 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 number of bacteria needed to produce a bone infection is reduced 10000 times in the presence of beeswax. A recent study published in 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 will not regenerate – a major problem for a heart patient hoping for his cut sternum to heal.

OsteneTM offers the first affordable and effective alternative to beeswax – without the side effects. The water-soluble ingredients in OsteneTM have a long history of medical use – poloxamer in the product is a common inactive compound used in many pharmaceuticals. Completely synthetic in origin, OsteneTM doesn’t increase the risk of infection or cause allergic reactions. It allows the bone to heal without causing an inflammatory response. Unlike beeswax, OsteneTM is eliminated from the body within 48 hours after surgery and doesn’t react with the body’s chemistry.

Most surgeons performing cardiac, orthopedic or neurospinal procedures are unaware of the side effects of beeswax. Most patients don’t know they will wake up after surgery with a layer of beeswax inside them.

Heart surgeons, who perform 380,000 coronary artery bypass operations in the United States each year, start by cutting open the sternum. Hip and knee reconstructions, bunion corrections, cranial and neurospinal procedures all require cutting the living bone. To stop the bone from bleeding, most doctors still use the old Civil War-era remedy.

OsteneTM finally gives the living human bone what it deserves: the long-overdue benefit of 21st- century medicine.

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Anna Chodakiewicz Wellisz
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