|
Bone wax is made of beeswax containing a softening agent such as paraffin. Once applied, it essentially never goes away. Although inexpensive, easy to use and immediate, beeswax has a number of adverse reactions associated with it.
1) Bone wax inhibits formation of new bone (osteogenesis) and acts a physical barrier preventing bone union.1-4 In the presence beeswax, osteoblasts will be absent in a bone defect.5 In defects where beeswax was applied and removed after 10 minutes, there was complete inhibition of bone regeneration.6 For this reason beeswax is almost never used in areas where bone fusion is critical.7
2) Bone wax increases infection rates. Beeswax is known to increase infection rates and it significantly impairs the ability of bone to clear bacteria.8 In the presence of bone wax, the number of bacteria needed to produce osteomyelitis is reduced by a factor of 104 (10,000).9 In a recent study of infection rates following spinal surgery, 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.10
Infection and non-union are a particularly important problem in cardiac surgery.11 380,000 coronary artery bypass procedures are performed in the US per year. According to the American Heart Association, the incidence of deep sternal wound infections is 1% to 4%. Of these, up to 25% die, and the rest are subject to a complicated and costly recovery. The use of Ostene® could have an important impact in reducing these complications.
3) Bone wax remains as a foreign body for many years, and can cause a giant cell reaction and local inflammation.12, 13 In skull base surgery, beeswax has been reported to cause granuloma formation and CSF fluid leaks.14, 15
Ostene®
Ostene® is an excellent solution when the complications of beeswax need to be avoided and immediate hemostasis is required. Ostene® is made from a water-soluble blend designed to look and feel like bone wax. Ostene® is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. These copolymers have a long history in the medical and pharmaceutical fields, and they are considered inert. The poloxamer that is used is a common inactive ingredient in pharmaceutical preparations.
Recent animal data has demonstrated that Ostene® does not increase infection rates, does not interfere with bone healing, and is non-inlfammatory (data available upon request).
Other bone hemostasis methods
Another way to stop bone bleeding is to use a clotting agent such as thrombin applied to a gelatin sponge. This combination stops most bone bleeding within several minutes. In addition to not working instantaneously, these products are very expensive and can have complications (please see summary).
References (An expanded reference list is also available)
1. Wellisz T, Armstrong JK, Cambridge J, Fisher TC: Ostene, a new water-soluble bone hemostasis agent. J Craniofac Surg 17: 420-425, 2006.
Ostene was compared to bone wax in a femur defect model. Bone wax elicited a foreign body response consisting of fibrous tissue infiltrated by macrophages, giant cells and lymphocytes and interfered with bone ingrowth. Ostene showed no evidence of an adverse response in the cortical defect site, medullary cavity, or the surrounding tissue at 4 and 8 weeks.
2. 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.
3. 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.
Bone wax (Ethicon) was compared 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 bone healing was observed as early as 10 days.
4. 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: S89–S96, 2004.
A review article of hemostasis agents used in spinal surgery describes the complications of beeswax including the risk of infection.
5. 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 of the effects of bone wax on the healing of membranous cranial bone in rabbits. Bone wax was applied to the cut margin of bone. 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. There was no evidence of bone formation and no osteoblasts were seen on bone surfaces covered with bone wax.
6. 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 (Ethicon) 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.
7. Brightmore TG, Hayes P, Humble J, Morgan AD: Hemostasis and healing following median sternotomy. Langenbecks Arch Chir, [Suppl]: 39–41, 1975.
Autopsies were performed on 5 patients who died up to 6 years following median sternotomy. Bone wax interfered with healing in every patient. Bone wax was also shown to form a barrier to bone healing in sternotomized goats, causing absorption of cancellous bone and inhibiting osteogenesis.
8. 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. Bone wax significantly impaired the ability of cancellous bone of rabbits to clear a standard inoculum of Staphylococcus aureus.
9. 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 study the effect of bone wax on experimental Staphylococcus aureus osteomyelitis. The presence of bone wax reduced the amount of bacteria needed to produce osteomyelitis by a factor of 104 (10,000).
10. 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.
11. Robicsek F, Masters TN, Littman L, Born GVR. The embolization of bone wax from sternotomy incisions. Ann Thorac Surg 31:357–359, 1981.
Radioactive bone wax was used on the cut sternum in animals. There were radioactive deposits in peripheral lung tissue, 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.
12. Allison RT: Foreign body reactions and an associated histological artefact 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.
13. 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 in the iliac crest in dogs were filled with common hemostatic agents. 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.
14. 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.
15. 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.
|
|
