Ostene, a New Water-Soluble Bone Hemostasis Agent

Abstract

Traditional formulations of bone wax are composed largely of beeswax and are well known to interfere with bone healing and cause inflammatory reactions. Ostene, a newly available bone hemostasis agent made of water-soluble alkylene oxide copolymers, was evaluated. The soft tissue response to Ostene was compared with bone wax and a polyethylene control after implantation into the paravertebral muscles of three rabbits. After 2 weeks, Ostene elicited no fibrous response, the polyethylene elicited a thin (less than 0.5 mm) fibrous response, and the bone wax was encased in a fibrous capsule 0.6 to 1.0 mm thick infiltrated with inflammatory cells. The effects of Ostene were compared with bone wax in a femur defect model in eight rabbits. Ostene showed no evidence of an adverse response in the cortical defect site, medullary cavity, or the surrounding tissue at 4 and 8 weeks. In contrast, bone wax at both time intervals elicited a foreign body response consisting of fibrous tissue infiltrated by macrophages, giant cells, and lymphocytes at the sites of the bone defects. Bone wax also displaced the bone marrow and interfered with bone ingrowth into the defects. Ostene provides the clinician a water-soluble bone hemostasis material that does not demonstrate the adverse tissue response or the interference with bone healing seen with the use of bone wax.

Efficacy and Safety of Bone Wax to Reduce Sternal Bleeding Following Coronary Bypass Surgery

“…11) Many different materials, such as calcium phosphate cement, absorbable microfibrillation collagen, fibrins and dissoluble alkylene oxide copolymers were used instead of bone wax to control the bleeding on sternal sides, and their properties were compared with bone wax. [12][13][14] In our study, any statistically significant difference was not found between groups considering the quantity of bleeding, amount of blood and blood products used and deep sternal infection. It could not be shown that the application of bone wax significantly reduces bleeding following sternotomy.…”

Management of Bone Bleeding During Surgery and Its Impact on the Incidence of Post-Operative Osteomyelitis

“…Once applied to bone, bone wax remains at the site indefinitely. Bone wax is known to interfere with bone healing, elicit chronic inflammatory reactions, and increase infection rates (Allison, 1994;Chun, 1988;Finn, 1992;Johnson, 1981;Nelson, 1990;Gibbs, 2004;Sawan et al, 2010;Wellisz et al, 2006Wellisz et al, , 2008aWellisz et al, , 2008b. 7 And yet, the use of bone wax remains relatively widespread, and surgeons are often unaware of the complications surrounding its application.…”

“…Once applied to the bone, the material remains at the surgical site indefinitely. It may become a nidus of infection and if contaminated, it may cause infection of the soft tissue or osteomyelitis (Allison, 1994;Chun et al, 1988;Finn et al, 1992;Gibbs et al, 2004;Johnson et al, 1981;Nelson et al, 1990;Wellisz et al, 2006Wellisz et al, , 2008aWellisz et al, , 2008b.…”

“…49 These copolymers are inert, and they are eliminated from the body unmetabolized via the kidneys and liver. Recent research in animal models has shown that AOC based product does not increase infection rates, does not promote inflammation, and does not interfere with bone healing Magyar et al, 2008;Sawan et al, 2010;Wellisz et al 2006Wellisz et al , 2008aWellisz et al , 2008b. 50 An AOC based bone hemostasis material (Ostene ® ) has been available since 2006 and is currently distributed by Baxter International, Inc.…”

Preparation of novel hemostatic material containing spherical porous hydroxyapatite/alginate granules

“…The conventional bone wax is chiefly composed of beeswax but this material sometimes interferes with bone healing by causing an inflammatory reaction. 1) Moreover, the beeswax has some possibility of causing infection, because it derives from animals. Thus novel materials are needed in order to avoid such infection and to promote bone healing without causing an inflammatory reaction.…”