Efficacy and safety of a novel hemostatic material, BoneStat, compared with Ostene and Bone Wax in a rat calvarial defect model

Abstract

Hemostasis has critical significance during surgical procedures. Bone Wax has traditionally been commonly used for bone hemostasis despite well-documented undesirable side effects: hindering osteogenesis and induction of inflammatory reactions with consequent increase in infection rates. A later developed formulation, Ostene, offers an alternative to Bone Wax with lesser undesired effects. In this study, BoneStat, a newly developed bone hemostatic formulation comprising water-soluble alkylene oxide co-polymers, was evaluated for water solubility, hemostatic efficacy, ease of handling, bone healing efficacy, and inflammatory reactions compared with Bone Wax and Ostene in a rat calvarial defect model. More than 95% of BoneStat was dissolved in water within 48 h, as was Ostene, but not Bone Wax. The time to hemostasis using BoneStat was significantly faster than with Ostene or Bone Wax. BoneStat also improved ease of handling compared to Ostene or BoneWax. BoneStat- and Ostene-treated groups constantly showed better bone healing than with Bone Wax. The BoneStat and Ostene groups presented no evidence of chronic inflammation reaction contrary to Bone Wax. These results suggest improved hemostasis, ease of handling, non-hindering bone healing, and unnoticeable chronic inflammatory reactions with BoneStat. Thus, Bonestat is a useful and reliable formulation for mechanical hemostasis.

Rational Design of Bioactive Materials for Bone Hemostasis and Defect Repair

“…In addition, Pluronic can promote cartilage tissue formation, facilitate the vascularization of injured bone tissue, and protect periodontal bone [ 95 , 96 ]. BoneStat, a newly developed bone hemostatic material, has the advantages of promoting hemostasis, simple operation, and autonomous degradation [ 97 ]. Polyethylene glycol (PEG) is also representative of traditional hemostatic materials.…”

Novel resorbable bone wax containing β-TCP and starch microspheres for accelerating bone hemostasis and promoting regeneration

“…To avoid the problems associated with traditional bone wax, new resorbable synthetic substitutes have been developed, including PEG/microfibrillar collagen composites ( Orgill et al, 2015 ), alkylene oxide copolymers ( Salim, 2018 ; Kim et al, 2020 ; Choi et al, 2021 ), hydroxyapatite/polylactic acid ( Tham et al, 2018 ), alkylene oxide copolymers/carboxymethylcellulose sodium salt composites, poly (ethylene glycol)-poly (propylene glycol) copolymer/starch composites ( Suwanprateeb et al, 2014 ), modified calcium sulfate cement ( Zhou et al, 2018 ), and chitosan ( Chen et al, 2015 ). However, absorbable materials might cause allergic reactions and retardation of bone regeneration ( Schonauer et al, 2004 ).…”

Evaluating the Efficacy of Water-Soluble Bone Wax (Tableau Wax) in Reducing Blood Loss in Spinal Fusion Surgery: A Randomized, Controlled, Pilot Study

“…Although the clinical usefulness of water-soluble bone wax materials has been reported in several studies [ 9 , 10 , 11 ], its efficacy in spine surgery remains less well-established. Therefore, this study aims to evaluate the effectiveness of Tableau wax on bone hemostasis in patients undergoing spinal fusion surgery through a pilot study.…”