*NEW. Wellisz T, An YH, Wen X, Kang Q, Hill CM, Armstrong JK: Infection Rates and Healing Using Bone Wax and a Soluble Polymer Material. Clin Orthop Relat Res 466:481–486, 2008.
The effects of using Ostene in a contaminated environment were assessed in a rabbit tibial defect model. Infection rates and healing of Ostene-treated bone were compared with the infection and healing of bone wax-treated bone and untreated controls after a bacterial challenge. Defects created in 24 rabbit tibias were treated with the Ostene or bone wax, or left without a hemostatic agent. The defects were inoculated with Staphylococcus aureus ATCC-29213 (2.5 X 10⁴ colony-forming units). After 4 weeks, all defects treated with bone wax were infected and osteomyelitis had developed, and none had evidence of bone healing. In the Ostene and control groups, two defects in each group (25%) had osteomyelitis develop. The remaining six defects in each group (75%) showed no osteomyelitis and exhibited normal bone healing. The Ostene-treated defects had a considerably lower rate of osteomyelitis and positive bone cultures compared with the bone wax-treated group. There were no differences between the polymer-treated and control groups in the rates of osteomyelitis, positive cultures, or bone healing. The use of Ostene, a soluble polymer as an alternative to bone wax may decrease the rates of postoperative bone infections.

*NEW. Wellisz T, Armstrong JK, Cambridge J, An YH, Wen X, Hill CM, Fisher TC: The effects of a soluble polymer and bone wax on sternal healing in an animal model. Ann Thorac Surg 2008.

The effects of a soluble polymer hemostatic material and bone wax on sternal bone healing were compared. Median sternotomies were performed on 20 NZW rabbits, and sufficient Ostene or bone wax was applied to achieve bone hemostasis. After 6 weeks, sternal healing was assessed using roentgenograms, histology, and mechanical strength testing. Roentgenograms revealed normal bone healing in the Ostene-treated group and nonunion in the bone wax group. Histology showed normal bone healing in the Ostene group, with fibrotic scar tissue and the absence of new bone formation in the bone wax group. Mechanical strength testing showed that Ostene -treated sternal segments were twice as strong as those treated with bone wax. They had a significantly higher flexural strength (p < 0.001) and Young’s modulus (p < 0.001). The application of Ostene to the sternum resulted in significantly stronger union compared with the use of bone wax.

1. Alberius P, Klinge B, Sjogren S: Effects of bone wax on rabbit cranial bone lesions. J Craniomaxillofac Surg 15(2):63–67, 1987.
A study the local effects of bone wax on the healing of membranous cranial bone in the calvarial bone of rabbits. Bone wax was applied to the cut margin of bone as apposed to filling the entire defect with a plug of bone wax. Three stages of bone and tissue reaction to bone wax were identified: 1) A nonspecific inflammatory response; 2) a foreign body reaction; and 3) a marked fibrous reaction. The authors noted that there was no evidence of bone formation and there were no osteoblasts seen on bone surfaces covered with bone wax.

 2. Allison RT: Foreign body reactions and an associated histological artifact due to bone wax. Br J Biomed Sci 51: 14–17, 1994.
The author describes four patients who required reoperation for removal of infected bone wax 6 months to 2 years following initial maxillofacial surgery. Foreign body giant cell reactions, chronic inflammation were seen in the specimens.

 3. Anfinsen OG, Sudmann B, Rait M, Bang G, Sudmann E: Complications secondary to the use of bone wax in seven patients.  J Foot Ankle Surg 32: 505–508, 1993.
Seven women required re-operation after developing disabling pain and tenderness attributed to bone wax 4 to 52 months following foot surgery. Bone wax granulomas with marked foreign body reactions were removed in all seven patients.

 4. Angelini GD, el-Ghamari FA, Butchard EG. Post-sternotomy pseudo-arthrosis due to foreign body reaction to bone wax. Eur J Cardiothorac Surg 1: 129-30, 1987.
A report of a foreign body reaction and pseudo-arthrosis of the sternum following coronary artery bypass grafting.

5. Armstrong JK, Fisher TC, Cambridge JS, Kang Q, An YH, Wen X, Wellisz T: The Effects Of Bone Wax And Ostene, A Newly Available Water-Soluble Synthetic Bone Hemostasis Material, On Sternal Healing Following Median Sternotomy In An Animal Model. To be presented at the Annual Meeting of the American Association for Thoracic Surgery, 2007.
Median sternotomies were performed on 20 female New Zealand White rabbits and either bone wax (Ethicon, Inc.) or alkylene oxide copolymer (Ostene®, Ceremed, Inc.) was applied to the cut bone surface. After 6 weeks, histological analysis showed massive fibrotic scar tissue with no evidence of new bone formation in the bone wax group. Bone healing and new bone formation, as evidenced by regenerated bone trabeculae and marrow structure, were observed in the alkylene oxide copolymer group without any observation of fibrotic scar tissue. Mechanical testing of the sterna showed an approximate two-fold greater flexural strength (2.53 ± 0.43 versus 1.29 ± 0.37 MPa) and two-fold greater Young's modulus (0.315 ± 0.056 versus 0.146± 0.031 MPa) in the alkylene oxide copolymer group compared to the bone wax group.

 6. Bolger W, Tadros, M, Ellenbogen R, Judy K, Grady M: Endoscopic management of cerebrospinal fluid leak associated with the use of bone wax in skull-base surgery. Otolaryngol Head Neck Surg 132: 418-420, 2005.
Three patients presented with brisk CSF leaks following skull-base surgery where bone wax was used for hemostasis. Sinus endoscopy revealed bone wax with a small parasphenoid defect in each case.

 7. Brightmore TGJ: Haemostasis and healing following median sternotomy. Br J Surg 62:152, 1975.
Autopsies were performed on 5 patients who died up to 6 years following median sternotomy and an obstructive effect on healing following the use of bone wax was seen each patient. Bone wax forms a barrier to bone healing in sternotomized goats, causing absorption of cancellous bone and inhibiting osteogenesis.

 8. Chun PKC, Virmani R, Mason TE, Johnson F. Bone wax granuloma causing saphenous vein thrombosis. Am Heart J 115: 1310-13, 1988.
A report of a bone wax granuloma following cardiothoracic surgery which compressed the patient’s saphenous vein graft leading to a myocardial infarction.

 9. Dos Santos Neto FL, Volpon JB. Experimental nonunion in dogs. Clin Orthop 187: 260 – 271, 1984.
Bone wax used in the radius of dogs prevented bone healing and was used to create experimental non-unions.

10. Finn MD, Schow SR, Schneiderman ED: Osseous regeneration in the presence of four common hemostatic agents. J Oral Maxillofac Surg 50(6): 608–612, 1992.
Surgical defects of the iliac crest were made in dogs and filled with common hemostatic agents. The defects filled with bone wax showed intense foreign-body reactions characterized by giant cells, plasma cells, fibrous tissue, and a lack of bone formation. It was concluded that bone wax should not be used as a hemostatic agent during iliac crest graft harvesting.

11. Gibbs L, Kakis A, Weinstein P, Conte J: Bone wax as a risk factor for surgical-site infection following neurospinal surgery. Infect Control Hosp Epidemiol 25: 346-348, 2004.
The infection rates were monitored in one institution during a 3-month period. Surgical site infections occurred in 6 of 42 cases in which bone wax was used, and in only 1 of 72 cases in which it was not used. In all cases the infections occurred in laminectomy patients. The time from surgery to positive culture ranged from 8 to 79 days following surgery. 

12. Hadeishi H, Yasui N, Suzuki A: Mastoid Canal and Migrated Bone Wax in the Sigmoid Sinus: Technical Report. Neurosurgery 36(6):1220-1224, 1995.
A study of the migration of bone wax into the sigmoid sinus through the mastoid canal is reported. In 7 of 161 patients who underwent retromastoid craniectomy, the postoperative soft tissue window image computed tomographic scans demonstrated a mass in the sigmoid sinus 1 month to 2 years after surgery. In 2 of the 7 patients, the sigmoid sinus was occluded. It is concluded that the application of a large quantity of bone wax to control the bleeding from the emissary veins carries a risk of the migration of bone wax into the sigmoid sinus. The use of bone wax should be minimized in order to prevent sigmoid sinus occlusion.

13. Howard TC, Kelley RR: The effect of bone wax on the healing of experimental rat tibial lesions. Clin Orthop 63:226–232, 1969.
Holes drilled in the tibias of rats were packed with bone wax. New bone formation was inhibited and there was no microscopic evidence on bone formation in the holes plugged with bone wax. Bone wax created pseudoarthrosis. The authors concluded that bone wax is contraindicated in the areas of bone fusion. They commented that there seems to be no universal knowledge or acceptance of the idea.

14. Ibarrola JL, Bjorenson JE, Austin BP, Gerstein H (1985) Osseous reactions to three hemostatic agents. J Endod 11(2): 75–83, 1985.
A rat tibial defect model was employed to study the effects of hemostatic agents. Bone wax inhibited osteogenesis and caused marked inflammation. In defects where the bone wax was applied, and then removed after 10 minutes, there was complete inhibition of bone regeneration.

15. Johnson P, Fromm D: Effects of bone wax on bacterial clearance. Surgery 89: 206–209, 1981.
Bone wax lowers the bacterial clearance in cancellous bone. The cancellous bone of the iliac crest of rabbits was penetrated with and without Staphylococcus aureus followed by the placement of bone wax or a steel rod. It appeared that bone wax significantly impaired the ability of cancellous bone of rabbits to clear a standard inoculum of Staphylococcus aureus.

16. Nelson DR, Buxton TB, Luu QN, Rissing JP: The promotional effect of bone wax on experimental Staphylococcus aureus osteomyelitis. J Thorac Cardiovasc Surg 99: 977–980, 1990.
A rat tibia model was used to effect of bone wax on experimental Staphylococcus aureus osteomyelitis. The presence of bone wax reduced the amount of bacteria needed to produce osteomyelitis by 99.9%.

17. Papay FA, Morales L, Ahmed OF, et al. Comparison of ossification of demineralized bone, hydroxyapatite, Gelfoam and bone wax in cranial repair. J Craniofac Surg 7:347-351, 1996.
The authors studies the effect of four agents on bone healing in human calvarial defects and found that the least amount of healing occurred in defects filled with bone wax.

18. Patel RB, Kwatler JA, Hodosh RM. Bone wax as a cause of body granuloma in the cerebellopontine angle: case illustration. J Neurosurg  92: 362, 2000.
A patient is described who had an expanding mass after a 1 cm intracranial tumor was resected. The mass grew to 2 X 2.5 cm, and on resection was found to be foreign body granulomatous reaction to beeswax.

19. Robicsek F, Masters TN, Littman L, Born GVR. The embolization of bone wax from sternotomy incisions. Ann Thorac Surg 31:357–359, 1981.
In animal experiments in which radioactive bone wax was used on the cut sternum, there was evidence of radioactive deposits in peripheral lung tissue, thereby indicating bone wax embolization. The authors suggested that embolization occurs under clinical conditions and may play a role in the development of postoperative pulmonary complications.

20. Samii M, Matthies, C: Management of 1000 Vestibular Schwannomas (Acoustic Neuromas): Surgical Management and Results with an Emphasis on Complications and How to Avoid Them. Neurosurgery 40(1):11-23, 1997.
The authors describe eight patients who required revisional surgery, 6 for infection and 2 for bone wax allergy. Since the use of bone wax on the mastoid was stopped, no further revisional surgery was required.

21. Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A: The use of local agents: bone wax, gelatin, collagen, oxidized cellulose Eur Spine J 13 (Suppl. 1): S89–S96, 2004.
A review article of hemostasis agents used in spinal surgery describes the complications of beeswax including the risk of infection. 

22. Sorrenti SJ, Cumming WJ, Miller D, Path FF. Reaction of the human tibia to bone wax. Clin Orthop 182: 293–296, 1984.
The authors evaluated the reaction to bone wax in human tibias in 12 adult patients who had undergone tibial tubercle elevation. The patients were underwent reoperation 5 to 13 months later and bone biopsies were performed. A progression from foreign body giant cell reaction and young fibrous tissue to mature fibrous tissue was noted. Many of the giant cells were noted to contain vacuoles filled with bone wax.

23. Sudmann B, Bang G, Sudmann E: Histology verified bone wax (beeswax) after median sternotomy in 17 of 18 autopsy cases.  Pathology 38: 138-141, 2006.
An autopsy study examined the sterna of 18 patients who had undergone median sternotomy. In 17 of the patients residual bone wax was found up to 10 years following surgery. In each of these cases, the bone wax had elicited an inflammatory reaction containing multinucleated giant cells.

24. Wang MY, Armstrong JK, Fisher TC, Meiselman HJ, McComb GJ, Levy ML: A new, pluronic-based, bone hemostatic agent that does not impair osteogenesis. Neurosurgery 49: 962-968, 2001.
The authors compare beeswax (Ethicon) to a Pluronic blend in two rat bone defect models. There was no evidence of bone healing in the defects filled with beeswax even after 42 days. The defects filled with the Pluronic blend healed as well as the control groups, and progressive bone healing was observed as early as 10 days.

25. Wellisz T, Armstrong JK, Cambridge J, Fisher TC: Ostene, a new water-soluble bone hemostasis agent. J Craniofac Surg 17: 420-425, 2006.
The soft tissue response to Ostene was compared to bone wax and a polyethylene control after implantation into the paravertebral muscles of rabbits. After two 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 mm to 1.0 mm thick infiltrated with inflammatory cells. The effects of Ostene were compared to bone wax in a femur defect model in 8 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.

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