lberius, P., B. Klinge, et al. (1987). "Effects of bone wax on rabbit cranial bone lesions." J Craniomaxillofac Surg 15(2): 63-67.
The present study was designed to elucidate the reactions of cranial membranous bone-to-bone wax. In ten young rabbits, twenty parietal bone defects were created by drilling, the edges of which were partly extended using rongeur forceps to enable investigation of eventual thermal effects. Half of the marginal bone surrounding the lesions was covered by bone wax, the remainder serving as control. The animals were sacrificed 1 and 7 weeks after surgery, and block specimens prepared for light microscopy. Merely slight tissue reactions to the bone wax were discerned. Bony regeneration occurred mainly from the dura mater and the pericranium, but also from the bony rim. Reskeletalization was markedly impaired by the presence of bone wax. Heat generated by drilling caused reduced bone formation despite constant irrigation perioperatively. Clinical consequences are discussed.
Allison, R. T. (1994). "Foreign body reactions and an associated histological artefact due to bone wax." Br J Biomed Sci 51(1): 14-17.
Bone wax has been used since the turn of the century as a mechanical aid to haemostasis following surgical procedures. That it may produce a foreign body giant cell reaction in a significant proportion of cases is well known. The occurrence of this material in specimens received in the laboratory is poorly documented. Four cases are described to bring attention to this exogenous agent which, it is suggested, should feature in tables of pigments and other materials occurring in tissue specimens.
Anfinsen, O. G., B. Sudmann, et al. (1993). "Complications secondary to the use of standard bone wax in seven patients." J Foot Ankle Surg 32(5): 505-508.
Ordinary bone wax, manufactured from beeswax, was used to stop bleeding from cancellous bone in elective surgery among seven women. Five of them had a resection of a calcaneal exostosis and bursa at the insertion of the calcaneous tendon, one underwent a resection of a medial exostosis of the first metatarsal head, and one had an acromial resection. Postoperatively, all patients had disabling local pain and tenderness. Three of them developed firm visible swellings where bone wax had been used, which was easily palpable under the intact skin. At reoperation, 4 to 52 months later, masses of brown, soft granulation tissue were excised in all patients. Five of seven were relieved from pain. Microscopically, a bone wax granuloma with marked foreign body reaction was seen in all patients.
Block, J. E. (2005). "Severe blood loss during spinal reconstructive procedures: the potential usefulness of topical hemostatic agents." Med Hypotheses 65(3): 617-621.
Complex spinal reconstructive procedures are invariably associated with excessive intraoperative blood loss that significantly increases the risk of severe perioperative complications. In some cases, excessive hemorrhage is equivalent to estimated total blood volume. Unfortunately, widely exposed bony surfaces are not amenable to standard hemostatic maneuvers utilized during soft tissue surgery. This article evaluates the clinical effectiveness of several approaches to blood management in this setting, and hypothesizes that underappreciated topical hemostatic agents may provide benefit by reducing the need for autologous predonation, banked donor blood or antifibrinolytic agents. Topical agents combining collagen, thrombin and fibrin have demonstrated initial promise by inducing platelet aggregation and initiating the clotting cascade when applied directly to bleeding bony sites. Clinical studies are clearly warranted.
Bolger, W. E., M. Tadros, et al. (2005). "Endoscopic management of cerebrospinal fluid leak associated with the use of bone wax in skull-base surgery." Otolaryngol Head Neck Surg 132(3): 418-420.
OBJECTIVE: To alert otolaryngologists to consider the possibility that bone wax may be associated with cerebrospinal fluid leaks that occur immediately after skull-base craniotomy approaches. STUDY DESIGN AND SETTING: Clinical report from surgical experience in a tertiary care setting. RESULTS: Three patients presented with brisk cerebrospinal fluid leak after craniotomy. Sinus endoscopy revealed bone wax within a small parasphenoid defect in all 3 cases. CONCLUSIONS: Bleeding from areas of the skull base adjacent to the paranasal sinuses during craniotomy can signal a small breach of the skull base. Bone wax may control bleeding from edges of transected bone but also stent the skull-base defect open, preventing fibrin deposition and spontaneous healing and closure. SIGNIFICANCE: Otolaryngologists repairing a cerebrospinal fluid leak after a skull-base craniotomy approach should consider the possibility of encountering bone wax and be able to identify it to better treat their patient.
Finn, M. D., S. R. Schow, et al. (1992). "Osseous regeneration in the presence of four common hemostatic agents." J Oral Maxillofac Surg 50(6): 608-612.
The iliac crest is a common site for bone procurement in oral and maxillofacial surgery. The goal of this study was to evaluate the potential for bone regeneration in the presence of four common hemostatic agents in a manner that parallels iliac bone procurement in humans. The agents evaluated were 1) Avitene (microfibrillar collagen; Medchem Products, Inc, Woburn, MA); 2) bone wax (beeswax with isopropyl palmitate; Ethicon, Inc, Somerville, NJ); 3) Gelfoam (absorbable gelatin sponge; The Upjohn Company, Kalamazoo, MI); and 4) Surgicel (oxidized regenerated cellulose; Johnson & Johnson Products, Inc, Patient Care Division, New Brunswick, NJ). Five surgical defects in each of four dogs were created for placement of the four materials; one defect served as an empty control site. The dogs were then allowed to heal over a 2-month period. Radiographic and histologic examination showed new bone formation in the presence of Avitene, Surgicel, and Gelfoam. Residual material incorporated in bone, without foreign-body response, was noted in the Avitene and Gelfoam sites. Bone wax, however, showed an intense foreign-body reaction, characterized by giant cells, plasma cells, fibrous granulation tissue, and lack of bone reformation. On the basis of these initial findings, it was concluded that Surgicel, Avitene, and Gelfoam might be adequate hemostatic agents for use in iliac bone procurement, whereas the use of bone wax appears to be contraindicated.
Gibbs, L., A. Kakis, et al. (2004). "Bone wax as a risk factor for surgical-site infection following neurospinal surgery." Infect Control Hosp Epidemiol 25(4): 346-348.
Surgical-site infection occurred in 6 of 42 neurospinal cases in which bone wax was used and in 1 of 72 cases in which it was not used during a 3-month period (P < .01). Increased risk of infection should be considered when using bone wax as a hemostatic agent.
Hadeishi, H., N. Yasui, et al. (1995). "Mastoid canal and migrated bone wax in the sigmoid sinus: technical report." Neurosurgery 36(6): 1220-1223; discussion 1223-1224.
A study of the migration of bone wax into the sigmoid sinus through the mastoid canal is reported here. In 7 of 161 patients who underwent retromastoid craniectomy, the postoperative soft tissue window image computed tomographic scans demonstrated a hypodense mass in the ipsilateral sigmoid sinus. The density value of the hypodense mass ranged from -34 to -79 Hounsfield units, which was neither as low as that of air nor as high as that of cerebrospinal fluid, but was comparable to that of fat tissue or bone wax. The continued presence of all of these masses in the sigmoid sinus was confirmed 1 month to 2 years after surgery. These computed tomographic findings suggested that this abnormal hypodense mass might be a migrated fragment of the bone wax that had been used for the control of venous bleeding from the mastoid emissary vein, because each of the seven affected patients had a large mastoid foramen and a large quantity of bone wax had been needed to control the bleeding during retromastoid craniectomy. No other material with the potential to migrate into the sigmoid sinus had been applied as a packing material. In two of the seven patients, venous magnetic resonance angiography after surgery demonstrated that the ipsilateral sigmoid sinus was not patent and the computed tomographic scans also revealed that the hypodense masses occupied the sigmoid sinus. It is concluded that the intrasurgical application of a large quantity of bone wax to control the bleeding from the large emissary veins carries a risk of the migration of bone wax into the sigmoid sinus. (ABSTRACT TRUNCATED AT 250 WORDS)
Howard, T. C. and R. R. Kelley (1969). "The effect of bone wax on the healing of experimental rat tibial lesions." Clin Orthop Relat Res 63: 226-232.
There has been a long-standing interest in hemostatic agents for osseous issue, as even in the early days of surgery it was apparent that it is very difficult and sometimes impossible to stop the flow of blood from exposed cancellous bone. In 1892, Horsley, a British neurosureon, decribed a hemostatic material for bone. This was a combination of beeswax, almond oil and salicylic acid that was known as “bone wax.” Its hemostatic action was physical (tamponade) rather than chemical. Its assess included ready availability, ease in preparing and handling and quick results. Though other approaches to osseous hemostasis have been tried, such as oxidized cellulose, bone dust, marrow paste, and combinations using polyethylene glycols, ordinary bone wax appears to be the agent most widely use today. It is surprising then to find that very little work has been done to define the local effect of bone wax on healing and osteogenesis and its eventual fate in either humans or animals. The present investigation, using an experimental lesion in rats, attempts to fill this void.
Ibarrola, J. L., J. E. Bjorenson, et al. (1985). "Osseous reactions to three hemostatic agents." J Endod 11(2): 75-83.
The effects of bone wax, Surgicel, and Gelfoam on bone healing were evaluated microscopically using two different intraosseous implantation techniques. Experimental defects were made in both tibias of rats. Test materials were placed in defects in right tibias and were left in situ for the duration of the experiment. Likewise, materials were placed in left tibial defects and then were removed as completely as possible after 10 min. All three hemostatic agenes affected healing when left in situ. Bone wax inhibited osteogenesis. Surgicel markedly slowed the rate of repair and cause inflammation. Gelfoam was usually completely resorbed and healing was complete 120 days after surgery. Residues of test materials were observed in most left tibial defects and they elicited reactions that were qualitatively similar but quantitatively less involved than those observed in the right tibias. These results indicate that careful removal of hemostatic agents during periapical surgery aids healing.
Johnson, P. and D. Fromm (1981). "Effects of bone wax on bacterial clearance." Surgery 89(2): 206-209.
The hemostatic benefit of bone wax placed in cancellous bone occurs at the expense of the wax persisting at the bony site for years. As such, bone wax appears to act as a foreign body. This study examines the effect of bone wax on the ability of cancellous bone to clear bacteria. The iliac crest of rabbits was penetrated to a standard depth with an 18-gauge needle. Subsequently, nothing or Staphylococcus aureus, 10(5) colony-forming units, was innoculated in the needle site and followed by the subcortical placement of a cylinder of bone wax or similarly sized stainless steel rod. Ten days later, the site of bony penetration was excised and cultured. Eighty percent of animals whose bone was implanted with bacteria and bone wax together had positive cultures. Forty percent of animals whose bone was implanted with bacteria and a steel rod also had positive cultures. The difference between these groups (bacteria with bone wax or with steel rod) was not statistically significant. However, these combinations of bacteria with foreign body were significantly different from the bacteria only or bone wax only or steel rod only groups in which no positive cultures were observed. The data indicate that bone wax significantly impairs the ability of cancellous bone of rabbits to clear a standard inoculum of S. aureus. This effect appears to be the same as that observed with a different but similarly sized foreign body (steel rod).
Lavigne, M., K. R. Boddu Siva Rama, et al. (2008). "Bone-wax granuloma after femoral neck osteoplasty." Can J Surg 51(3): E58-60.
Bone wax is widely used in various surgical specialties to control bleeding from bone surfaces. Surgeons should be aware of possible related complications. We report a case in which foreign-body reaction to bone wax applied over femoral neck osteoplasty required reoperation.
Nelson, D. R., T. B. Buxton, et al. (1990). "The promotional effect of bone wax on experimental Staphylococcus aureus osteomyelitis." J Thorac Cardiovasc Surg 99 Page: 6 (6): 977-980.
The consequences of using surgical bone wax are not well studied. We evaluated the infection-promoting potential of sterile bone wax in a rat model of chronic Staphylococcus aureus osteomyelitis. The addition of bone wax greatly reduced the quantitative bacterial inoculum (log colony-forming units) required to establish chronic osteomyelitis in 50% and 100% of challenged animals. The 50% infection rate was reduced from log 6.9 to 2.6 and the 100% infection rate from 8.2 to 4.4, respectively (p less than 0.015, t test for parallelism). Separate experiments were done 10 to 30 minutes after inoculation with only log 6.4 staphylococci. Tibiae of animals that received bone wax yielded more organisms than those that did not (log 2.76 +/- 0.68 versus 1.72 +/- 0.94, p less than 0.01). At 24 hours quantitative colony counts were not significantly different whether animals received wax or not (log 5.02 +/- 0.42 versus 4.43 +/- 0.65, p greater than 0.09). These studies suggest that the routine surgical use of bone wax should be reassessed.
Papay, F. A., L. Morales, Jr., et al. (1996). "Comparison of ossification of demineralized bone, hydroxyapatite, Gelfoam, and bone wax in cranial defect repair." J Craniofac Surg 7(5): 347-351.
Demineralized bone allografts in the repair of calvarial defects are compared with other common bone fillers. This study uses a video-digitizing radiographic analysis of calvarial defect ossification to determine calcification of bone defects and its relation to postoperative clinical examination and regional controls. The postoperative clinical results at 3 months demonstrated that bony healing was greatest in bur holes filled with demineralized bone and hydroxyapatite. Radiographic analysis demonstrated calcification of demineralized bone-filled defects compared to bone wax- and Gelfoam-filled regions. Hydroxyapatite granules are radiographically dense, thus not allowing accurate measurement of true bone healing. The results suggest that demineralized bone and hydroxyapatite provide better structural support via bone healing to defined calvarial defects than do Gelfoam and bone wax.
Patel, R. B., J. A. Kwartler, et al. (2000). "Bone wax as a cause of foreign body granuloma in the cerebellopontine angle. Case illustration." J Neurosurg 92(2): 362.
Bone wax is commonly used in a variety of surgical procedures as a hemostatic and sealing agent. It is particularly useful in neurosurgical procedures because of its inert, nonreactive characteristics and its ability to be molded to fill openings within the skull. Bone wax is generally a safe material and its use rarely leads to complications. To our knowledge, ours is the first case of an intracranial foreign body granuloma related to the use of bone wax.
Robicsek, F., T. N. Masters, et al. (1981). "The embolization of bone wax from sternotomy incisions." Ann Thorac Surg 31(4): 357-359.
We discuss our study on the effects of discontinuation of the usage of bone wax as a hemostatic agent in sternotomy incisions. In 1976, we abandoned use of bone wax because it was suspected of causing several cases of Mycobacterium fortuitum sternal osteomyelitis. In a retrospective study involving 400 patients, we found that this step did not increase postoperative bleeding as measured by drainage from the chest tube and by the need to return patients to the operating room because of bleeding. It also was observed that there was an appreciable simultaneous drop in pulmonary complications. To test our theory that the wax pressed into the bone marrow can embolize to the lung, radioactively tagged bone wax was pressed into the cut sternum in animal models, and a search was made for radioactive deposits in the peripheral lung tissue. Shortly after the application of the wax, there was evidence of large radioactive deposits in the lungs. It is probable that this embolization occurs also under clinical conditions and may play a role in pulmonary complications following open-heart operations.
Schonauer, C., E. Tessitore, et al. (2004). "The use of local agents: bone wax, gelatin, collagen, oxidized cellulose." Eur Spine J 13 Suppl 1: S89-96.
The use of local agents to achieve hemostasis is an old and complex subject in surgery. Their use is almost mandatory in spinal surgery. The development of new materials in chemical hemostasis is a continuous process that may potentially lead the surgeon to confusion. Moreover, the more commonly used materials have not changed in about 50 years. Using chemical agents to tamponade a hemorrhage is not free of risks. Complications are around the corner and can be due either to mechanical compression or to phlogistic effects secondary to the material used. This paper reviews about 20 animal and clinical published studies with regard to the chemical properties, mechanisms of action, use and complications of local agents.
Sherman, R., W. C. Chapman, et al. (2001). "Control of bone bleeding at the sternum and iliac crest donor sites using a collagen-based composite combined with autologous plasma: results of a randomized controlled trial." Orthopedics 24(2): 137-141.
In a randomized controlled trial, hemostatic effectiveness of a collagen-based composite (experimental group) was compared with standard hemostatic methods (i.e., electrocautery and collagen sponge) (control group) at two bone sites. Hemostatic success, time to "controlled bleeding," and time to "complete hemostasis" were determined at the sternal edge following median sternotomy (n=64) and at the iliac crest following bone graft harvest (n=19). Almost twice the percentage of sternal edge patients (83% versus 44%, P=. 002) and nearly three times the percentage of iliac crest patients (83% versus 29%, P<. 05) achieved complete hemostasis in the experimental group compared to controls. Time to controlled bleeding and complete hemostasis for all bone sites also favored the experimental group over the control group at highly significant levels (P<. 0001 for most comparisons). There were no adverse events related to experimental treatment use. The results support the use of this investigational hemostatic agent to control cancellous bone bleeding.
Sorrenti, S. J., W. J. Cumming, et al. (1984). "Reaction of the human tibia to bone wax." Clin Orthop Relat Res (182): 293-296.
In 12 patients treated by elevation of the tibial tubercle, bone wax was used to prevent bleeding from the cut surface. Biopsy specimens of the tissues obtained at the time of removal of the screws, five to 13 months after the operation, showed a definite foreign body giant cell reaction. Giant cells endocytosed bone wax from the site. The giant cell response culminated in a marked fibrous reaction.
Steingrimsson, S., R. Gustafsson, et al. (2009). "Sternocutaneous fistulas after cardiac surgery: incidence and late outcome during a ten-year follow-up." Ann Thorac Surg 88(6): 1910-1915.
BACKGROUND: Sternocutaneous fistulas (SCFs) after cardiac surgery represent a complex surgical problem involving multiple hospital admissions, prolonged antibiotic treatment, and repeated debridements. Our objective was to identify the incidence of and risk factors for SCF, and to evaluate long-term survival. METHODS: A total of 12,297 patients underwent sternotomy for cardiac surgery between January 1999 and December 2008, and 32 patients were diagnosed as having SCF during follow-up. Risk factors were identified with multivariate analysis and survival was compared using the log-rank test. RESULTS: The cumulative incidence of SCF at one year was 0.23%. There was no significant difference in mean time from sternal closure after cardiac surgery to intervention for SCF with (n = 9) or without (n = 23) preceding sternal wound infection (SWI); 6.1 +/- 4.2 versus 6.9 +/- 4.6 months, (p = ns). Risk factors for developing SCF were previous SWI (odds ratio [OR] = 15.7), renal failure (OR = 12.5), smoking (OR = 4.7), and use of bone wax during cardiac surgery (OR = 4.2). Negative-pressure wound therapy was applied in 20 cases of extensive SCFs. Five-year survival of SCF patients was 58% +/- 1% as compared with 85% +/- 4% in the control group (p = 0.003). CONCLUSIONS: Sternocutaneous fistula is a devastating diagnosis with significant morbidity and mortality. Previous SWI, renal failure, smoking, and use of bone wax are major risk factors. However, in a majority of patients SCF is not preceded by SWI and our results indicate that SCF may be a foreign body infection that develops in susceptible patients with risk factors for poor wound healing. Negative-pressure wound therapy may be a valuable adjunct in the treatment of extensive SCF.
Sudmann, B., G. Bang, et al. (2006). "Histologically verified bone wax (beeswax) granuloma after median sternotomy in 17 of 18 autopsy cases." Pathology 38(2): 138-141.
AIM: To evaluate the sternum from ordinary or forensic autopsy cases with a midline sternal cutaneous scar macro- and microscopically and using computed tomography (CT) to detect if the haemostatic bone sealant bone wax (beeswax) had been applied after median sternotomy and if the bone wax had elicited inflammation. METHODS: During a 3-year period, the sterna of 18 consecutive cadavers (15 ordinary autopsies, 3 forensic) who prior to death had undergone surgery with median sternotomy were examined macro and microscopically and with CT. In addition, one virgin sternum was smeared with bone wax at the upper half after bench sternotomy, sutured and examined with CT. Unused bone wax was examined with CT for attenuation measurements. RESULTS: Macroscopically, bone wax was seen in 17 of 18 sterna. Acute inflammation was found in one, chronic inflammation and foreign body multinucleated giant cells were seen around the bone wax in 17 sterna. No inflammation was found in one. CT could only detect foci in the operated sterna with attenuation values from -45 to +20 Hounsfield units (HU) and values about -80 HU were found in the virgin sternum. Unused bone wax measured about -100 HU. CONCLUSIONS: Bone wax is non-resorbable and induces chronic inflammation in the operated sternum up to 10 years after application. Measurement of Hounsfield units with CT of the operated sterna could not verify bone wax granuloma.
