Systemic and local reactions of a water-soluble copolymer bone on a bony defect of rabbit model

Lee, Tao-Chen; Chang, Nyuk-Kong; Su, Feng-Wen; Yang, Ya‐Chin; Su, Thung-Ming; Lin, Yujun; Lin, Wei-Chiang; Huang, Hsiu-Yu

doi:10.1016/j.surneu.2009.06.007

Cited by 7 publications

(7 citation statements)

References 11 publications

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“…Lee et al reported that bone wax can cause adhesions. 7 , 9 , 18 The current English-language literature does not offer any report on the effects of Ostene on PF. Our results revealed that Ostene has antifibrosis effect.…”

Section: Discussionmentioning

confidence: 99%

Is the use of hemostatic matrix (Floseal) and alkylene oxide copolymer (Ostene) safe in spinal laminectomies? Peridural fibrosis assessment

Gurcan

Gürçay

Kazanci

et al. 2017

Acta Orthopaedica et Traumatologica Turcica

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ObjectiveFailed Back Syndrome (FBS) is unacceptable relief of pain or recurrence of symptoms in patients after spinal surgery, such as laminectomy. One possible cause of FBS is peridural fibrosis (PF). PF is the overproduction of scar tissue adjacent to the dura mater. Bleeding can cause PF after laminectomy. Ostene is an alkylene oxide copolymer material used to stop bleeding from bony surfaces. Floseal is a gelatin thrombin matrix sealant used to assist fibrin formation and to promote coagulation.MethodsTotal of 32 female Sprague–Dawley rats were evenly allotted to 4 experimental groups: laminectomy only, laminectomy + Ostene (Baxter International, Inc., Deerfield, IL, USA), laminectomy + Floseal (Baxter International, Inc., Deerfield, IL, USA), and laminectomy + Adcon-L (aap Implantate AG, Berlin, Germany). After performing total laminectomy, agents were placed over dura mater. Spinal column of test subjects was harvested 6 weeks after laminectomy. Histopathological examination of samples was based on Masson's trichrome and hematoxylin and eosin staining. PF observed in the groups was graded using system previously described by He et al. Statistically significant p value was defined as p < 0.005.ResultsPresent study revealed that Adcon-L, Ostene, and Floseal groups had reduced PF compared with laminectomy only group (p = 0.001). Comparison of Ostene and Floseal groups with Adcon-L group yielded no significant difference.ConclusionReoperation as result of FBS has greater risk and often has poor outcome; surgeons must take precautions to avoid FBS, such as careful selection of appropriate patient and operation technique. Ostene and Floseal may be applied and left in the operation field safely during laminectomy to reduce occurrence of PF after procedure.

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Section: Discussionmentioning

confidence: 99%

Is the use of hemostatic matrix (Floseal) and alkylene oxide copolymer (Ostene) safe in spinal laminectomies? Peridural fibrosis assessment

Gurcan

Gürçay

Kazanci

et al. 2017

Acta Orthopaedica et Traumatologica Turcica

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“…Magyar et al analyzed bone healing in a rat calvaria defect model using micro-CT, and found that AOC treated defects healed as well as, and possibly earlier than controls [ 6 ]. In a study employing a rabbit iliac crest defect model, the authors concluded that AOC does not interfere with bone healing at 6 weeks when evaluated using light microscopy [ 30 ]. A water-soluble AOC wax comprised solely of poloxamers (polyoxyethylene-polyoxypropylene-polyoxyethylene triblock copolymers) was an effective bone hemostasis material that was not evident at the implantation site at 72 hours, showed good healing as early as 10 days post-surgery and healing was comparable to untreated defects up to 42 days in a rat femur defect model as determined by X-ray and histological analyses [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

The effect of three hemostatic agents on early bone healing in an animal model

et al. 2010

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BackgroundResorbable bone hemostasis materials, oxidized regenerated cellulose (ORC) and microfibrillar collagen (MFC), remain at the site of application for up to 8 weeks and may impair osteogenesis. Our experimental study compared the effect of a water-soluble alkylene oxide copolymer (AOC) to ORC and MFC versus no hemostatic material on early bone healing.MethodsTwo circular 2.7 mm non-critical defects were made in each tibia of 12 rabbits. Sufficient AOC, ORC or MFC was applied to achieve hemostasis, and effectiveness recorded. An autologous blood clot was applied to control defects. Rabbits were sacrificed at 17 days, tibiae excised and fixed. Bone healing was quantitatively measured by micro-computed tomography (micro-CT) expressed as fractional bone volume, and qualitatively assessed by histological examination of decalcified sections.ResultsHemostasis was immediate after application of MFC and AOC, after 1-2 minutes with ORC, and >5 minutes for control. At 17 days post-surgery, micro-CT analysis showed near-complete healing in control and AOC groups, partial healing in the ORC group and minimal healing in the MFC group. Fractional bone volume was 8 fold greater in the control and AOC groups than in the MFC group (0.42 ± 0.06, 0.40 ± 0.03 vs 0.05 ± 0.01, P < 0.001) and over 1.5-fold greater than in the ORC group (0.25 ± 0.03, P < 0.05). By histology, MFC remained at the application site with minimal healing at the defect margins and early fibrotic tissue within the defect. ORC-treated defects showed partial healing but with early fibrotic tissue in the marrow space. Conversely, control and AOC-treated defects demonstrated newly formed woven bone rich in cellular activity with no evidence of AOC remaining at the application site.ConclusionsEarly healing appeared to be impaired by the presence of MFC and impeded by the presence of ORC. In contrast, AOC did not inhibit bone healing and suggest that AOC may be a better bone hemostatic material for procedures where bony fusion is critical and immediate hemostasis required.

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“…BoneStat was in a paste form after manipulation and/or application at early times (within 12 h), which could act as a mechanical barrier in vivo, and then was rapidly dissolved at the site of application in vivo and in vitro, as well as were other water-soluble hemostatic agents. 4,6,39 BoneStat had almost disappeared within 48 h, even though it temporarily increased in material amount after 6 h, suggesting that BoneStat did not have any possibility of interfering with bone healing at least early after application. Due to their solubility properties (Figure 1), BoneStat and Ostene do not remain at the site of application, while Bone Wax remains (Figure 7).…”

Section: Discussionmentioning

confidence: 95%

“…Ostene (Ceremed, Inc., Los Angeles, CA, USA) is another mechanical hemostatic agent currently available for clinical application. Ostene is a water-soluble alkylene oxide copolymer 4,6,39 and is a US Food and Drug Administration-approved implant material indicated for use in the control of bleeding from bone surfaces. 4,6 Ostene is absorbable within 48 h after application at the bone surface.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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Systemic and local reactions of a water-soluble copolymer bone on a bony defect of rabbit model

Cited by 7 publications

References 11 publications

Is the use of hemostatic matrix (Floseal) and alkylene oxide copolymer (Ostene) safe in spinal laminectomies? Peridural fibrosis assessment

Is the use of hemostatic matrix (Floseal) and alkylene oxide copolymer (Ostene) safe in spinal laminectomies? Peridural fibrosis assessment

The effect of three hemostatic agents on early bone healing in an animal model

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

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