Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial.

BACKGROUND: Hypofibrinogenaemia is one of the main reasons for development of perioperative coagulopathy during major paediatric surgery. The aim of this study was to assess whether prophylactic maintenance of higher fibrinogen concentrations through administration of fibrinogen concentrate would decrease the volume of transfused red blood cell (RBCs). METHODS: In this prospective, randomised, clinical trial, patients aged 6 months to 17 yr undergoing craniosynostosis and scoliosis surgery received fibrinogen concentrate (30 mg kg(-1)) at two predefined intraoperative fibrinogen concentrations [ROTEM(®) FIBTEM maximum clot firmness (MCF) of <8 mm (conventional) or <13 mm (early substitution)]. Total volume of transfused RBCs was recorded over 24 h after start of surgery. RESULTS: Thirty children who underwent craniosynostosis surgery and 19 children who underwent scoliosis surgery were treated per protocol. During craniosynostosis surgery, children in the early substitution group received significantly less RBCs (median, 28 ml kg(-1); IQR, 21 to 50 ml kg(-1)) compared with the conventional fibrinogen trigger of <8 mm (median, 56 ml kg(-1); IQR, 28 to 62 ml kg(-1)) (P=0.03). Calculated blood loss as per cent of estimated total blood volume decreased from a median of 160% (IQR, 110-190%) to a median of 90% (IQR, 78-110%) (P=0.017). No significant changes were observed in the scoliosis surgery population. No bleeding events requiring surgical intervention, postoperative transfusions of RBCs, or treatment-related adverse events were observed. CONCLUSIONS: Intraoperative administration of fibrinogen concentrate using a FIBTEM MCF trigger level of <13 mm can be successfully used to significantly decrease bleeding, and transfusion requirements in the setting of craniosynostosis surgery, but not scoliosis. CLINICAL TRIAL REGISTRY NUMBER: ClinicalTrials.gov NCT01487837.

The phosphorous necrosis of the jaws and what can we learn from the past: a comparison of "phossy" and "bisphossy" jaw.

INTRODUCTION: The osteopathology of the jaws associated with bone resorption inhibitors is a current topic that engages a variety of clinical specialists. This has increased after the approval of denosumab for treatment of osteoporosis and skeletal-related events in patients with solid malignancy. Early after the first publications, there is a possible connection between phosphorous necrosis of the jaws, a dreadful industrial disease mentioned, and bisphosphonate-induced pathology. The nineteenth century was the prime time for phosphorus necrosis of match factory workers. RESULTS: This occurrence provides an interesting insight into the medical and surgical profession in the nineteenth century. There are striking parallels and repetition of current and old ideas in the approach to this "new disease." There are similar examples in case descriptions when compared with today's patients of bisphosphonate-related osteonecrosis of the jaws (BRONJ). DISCUSSION: Phosphorus necrosis was first described in Austria. Soon after this, surgeons in German-speaking countries including well-known clinicians Wegner (1872) and von Schulthess-Rechberg (1879) pioneered the analysis, preventative measures, and treatment of this disease. The tendency at this time was to approach BRONJ as a "special kind of osteomyelitis" in pretreated and metabolically different bone. Not only the treatment strategy to wait until sequestrum formation with subsequent removal and preventative measures but also the idea of focusing on the periosteum as the triggering anatomical structure may have been adopted from specialists in the nineteenth century. Therefore, phosphorous necrosis of the jaw is an excellent example of "learning from the past."

Osteopathology associated with bone resorption inhibitors - which role does Actinomyces play? A presentation of 51 cases with systematic review of the literature.

BACKGROUND: Bone resorption inhibitor-related osteopathology of the jaw (BRIOJ) is a severe complication in patients treated with bisphosphonates or denosumab. However, the precise pathogenesis of BRIOJ is not yet fully understood. Recent studies discovered the presence of Actinomyces colonies in biopsy material from BRIOJ patients. The aim of this study was to analyze current knowledge concerning the impact of Actinomyces on the pathogenesis of this condition and to present data from our own patients. METHODS: Data from 51 patients with histopathological diagnoses of BRIOJ were retrospectively analyzed. In addition, a systematic literature search for studies describing the presence of Actinomyces was performed. RESULTS: Actinomyces was present in 86% of our cases and 63.3% of 371 cases presented in the literature. All of our patients and 85% of patients described in the literature had a clearly defined local focus in association with osteopathology. A clear picture of whether Actinomyces colonizes the previously necrotic bone or contributes to inflammation causing subsequent bone necrosis is lacking in the literature. CONCLUSION: The pathogenesis of BRIOJ remains unknown; however, there seems to be a role for Actinomyces, and possibly other pathogens, in the development of osteopathology of the jaws, which is not exclusive to bisphosphonate therapy. This study supports the hypothesis that an infectious component is of utmost importance for the pathogenesis of BRIOJ.

Computer assisted maxillofacial surgery.

Technical developments strongly influence modern medicine. This is especially obvious in imaging technology. Today, one of the most difficult tasks for surgeons is transferring all the available imaging information for their patients into one "complete picture". In the operation theatre, this picture then has to be applied to the patient. Computer-assisted surgery (CAS) promises to help in fulfilling this task and, thereby, to fully utilize the possibilities offered by modern imaging techniques. Today's standard procedures for CAS in the maxillofacial region are described in technical principles and clinical applications. They are evaluated and discussed based on the available literature and in light of practical experience of more than ten years in the field of CAS. In addition, an outlook is given into developments of the near future that have appeared in the current literature. While technical development is leading toward a complete integration of all processes surrounding the patient and his or her surgery, basic CAS has moved from research to clinical care. Before it is routinely used, more investigation about its effectiveness and benefits has to be done, especially since increasing medical care costs are an issue in all countries.

Are allogenic or xenogenic screws and plates a reasonable alternative to alloplastic material for osteosynthesis--a histomorphological analysis in a dynamic system.

Despite invention of titanium and resorbable screws and plates, still, one of the main challenges in bone fixation is the search for an ideal osteosynthetic material. Biomechanical properties, biocompatibility, and also cost effectiveness and clinical practicability are factors for the selection of a particular material. A promising alternative seems to be screws and plates made of bone. Recently, xenogenic bone pins and screws have been invented for use in joint surgery. In this study, screws made of allogenic sheep and xenogenic human bone were analyzed in a vital and dynamic sheep-model and compared to conventional titanium screws over a standard period of bone healing of 56 days with a constant applied extrusion force. Biomechanical analysis and histomorphological evaluation were performed. After 56 days of insertion xenogenic screws made of human bone showed significantly larger distance of extrusion of on average 173.8 µm compared to allogenic screws made of sheep bone of on average 27.8 and 29.95 µm of the titanium control group. Severe resorption processes with connective tissue interposition were found in the histomorphological analysis of the xenogenic screws in contrast to new bone formation and centripetal vascularization of the allogenic bone screw, as well as in processes of incorporation of the titanium control group. The study showed allogenic cortical bone screws as a substantial alternative to titanium screws with good biomechanical properties. In contrast to other reports a different result was shown for the xenogenic bone screws. They showed insufficient holding strength with confirmative histomorphological signs of degradation and insufficient osseointegration. Before common clinical use of xenogenic osteosynthetic material, further evaluation should be performed.

[The range of craniosynostosis - timing and techniques of craniofacial repair]. / Das Spektrum der Kraniosynostosen - Timing und Techniken kraniofazialer Eingriffe.

Craniofacial anomalies show a wide spectrum of phenotypes and imply functional and esthetic disfigurement above all in cases of syndromal patients. The development in the field of craniofacial surgery during the last decades has brought us a system of highly standardized surgical procedures for the correction of the facial framework and the neighboring areas of the neurocranium which have only few tendencies for relapse. The feasibility of correction is nearby unlimited but implies sometimes considerable effort. As in other medical disciplines as well there is a risk of going beyond necessaries due to enthusiasm. The realistic assessment of patient's benefit must be the basis for the indication, timing and realization of each individual decision.

The galea fascia flap in orbital reconstruction: innovative harvest technique.

AIM: To report the treatment of a recurrent adenoid-cystic carcinoma of the lacrimal gland required orbital exenteration with an en bloc resection of the lateral orbital rim and wall and an anterior portion of the temporal muscle. Reconstruction was planned with both the objectives of a shortened healing time for faster epithetic reconstruction and no visible scars. METHOD: After a cranially extended temporal approach, the dissection of the superficial galea layer was connected with the subcutaneous dissection of the upper and lower eyelid after subciliary incisions. RESULTS: Ample exposure of the temporal, frontal and orbital region was obtained, facilitating the orbital exenteration with en bloc resection of the lateral orbital rim and wall and the anterior portion of the temporal muscle. The epithelialization of the eye socket covered with the galea fascia flap was accelerated, providing faster epithetic reconstruction, without visible scars. CONCLUSIONS: Healing time is accelerated, providing faster epithetic rehabilitation without visible scars, which is important in the postoperative rehabilitation ladder after eye exenteration for both patient and surgeon. Further more ablative surgery within this region gets safer and easier due to the ample exposure of this innovative surgical technique. Further evaluation of the effectiveness and safety of this new approach is advisable.

[Solitary abscessing osteomyelitis of the mandibular condyle. A rarity]. / Die solitäre abszedierende Osteomyelitis des Kieferköpfchens. Eine Rarität.

CASE REPORT: We report on a rare case of secondary chronic osteomyelitis of the left condyle. Haemophilus aphrophilus could be isolated from the abscess material. The condyle was resected and reconstructed with an endoprosthesis in the same operation. DISCUSSION: Possible causes of the rare location of secondary chronic osteomyelitis are assembled in a review of the literature and compared with the actual case. CONCLUSION: We suggest the inoculation of microorganisms through the needle of a local anesthetic injection, bacterial contamination during the tooth extraction, or bacteremia following the dental extraction to be possible causes for the infection.

Influence of different sterilization procedures and partial demineralization of screws made of bone on their mechanical properties.

Since 1992, screws made of allogenic, autoclaved human cortical bone have been employed as osteosynthesis materials. Autoclaving at 134 degrees C for 5 min makes them microbiologically safe, but on the other hand it reduces both their mechanical properties and osteoconductive capacity. The aim of this in vitro study was to determine if the mechanical properties of these screws could be improved after receiving different autoclaving procedures and partial inner demineralization, the latter additionally tending to increase their osteoconductive potential. 132 screws made of bovine cortical bone were employed. Some of them were partially demineralized with 0.6 N HCl from an inner canal performed following their longitudinal axis. All the specimens were autoclaved at 134 degrees C but under different vacuum conditions and sterilization time (A1-A2). They were then subjected to tension, shear and torque tests. A difference between both sterilization procedures was observed. Samples sterilized at 134 degrees C, 2-2.4 mbars for 5 min (A1) showed better mechanical properties than those autoclaved for longer time and higher vacuum conditions (A2). Demineralization also influenced their mechanical properties, being less resistant with increasing time. Based on these results, a standard screw made of bone and autoclaved at 134 degrees C, 2-2.4 mbars, 5 min seems to be the most appropriate, from a biomechanical point of view, to be used as osteosynthesis material.

Effects of enzymatic treatments on the biomechanical properties of screws made of bone.

Nowadays, bone tissue employed to manufacture screws used as osteosynthesis material is obtained from organ donors. But in different medical fields there is an increasing need to use xenogenic grafts and implants, which still imply risks of transmission of some diseases and antigenicity. Two different autoclaving programs (A1, A2) and an alternative to reduce the antigenicity of screws made of xenogenic bone based on enzymatic treatment are analyzed from a biomechanical point of view. 128 screws made of bovine femur bone were employed. Some of them were partially demineralized with 0.6 N HCl, enzymatically digested with collagenase (specific) and pepsin (nonspecific) and then autoclaved. The specimens were subjected to tension, shear and screw torque tests and histologically evaluated. Compared to A1, A2 sterilization method (134 degrees C but higher vacuum and longer time) considerably reduced the mechanical strength of specimens. The enzymatic digestion, expected to reduce antigenicity, did not affect the screw superficial structure and would not modify the bone biomechanical properties per se, but maybe because of the association with autoclaving and partial demineralization.

Volume variations of bone tissue after undergoing different physical and chemical treatments.

Both autogenic and allogenic bone has been employed through different surgical procedures to fill different defects or as osteosynthesis materials. Some physical and/or chemical treatments are usually necessary before its use. Since bone volume is important from a surgical point of view, the present study was designed to analyse its possible variations when subjected to certain procedures. Screws made of bovine cortical bone were autoclaved in different conditions regarding time and vacuum (A1-A2), cryopreserved, demineralised, enzymatically digested and rehydrated. The samples were measured before and after every treatment. Sterilisation caused a volume reduction more marked with method A1 than A2 whereas freezing allowed to obtain the original size. No volumetric changes were registered after demineralisation and enzymatic digestion. Rehydration significantly increased their volume already during the first hour but the maximum value was reached at 24 h. Thus, autoclaving was the only treatment able to reduce the bone volume whilst freezing and rehydration allowed the samples to return to their original size.

Evaluation of remifentanil as single drug for awake fiberoptic intubation.

BACKGROUND: Awake fiberoptic intubation is the standard of care for difficult airway management. Quality and success of this technique depend on the experience of the intubating physician and the proper preparation of the patient. The aim of this study was to compare remifentanil (R) as single agent to the combination of fentanyl (F) and midazolam (M), which have been the drugs for analgesia and sedation for this procedure. METHODS: Seventy-four adult patients requiring nasotracheal intubation were randomly assigned to one of two groups. In group I, (n=37) R was administered in incremental dosages (0.1-0.25-0.5 microg/kg/min) by an infusion pump according to comfort, level of sedation and respiratory depression. In group II, (n=37) analgesia and sedation was achieved by F 1.5 microg/kg and doses of between 1 and 10 mg M, titrated to the individual needs. Patient reactions like grimacing, movement and coughing during intubation were assessed, as well as patient recall of the procedure. Haemodynamic and respiratory parameters were continuously recorded. RESULTS: Group I patients better tolerated nasal tube passage (P<0.001) and laryngeal tube advancement (P<0.001) than group II. Remifentanil better suppressed hemodynamic response to nasal intubation (P<0.001). No significant difference in respiratory data was recorded. In group I more recall of the procedure was observed (six vs. zero patients, P<0.05). CONCLUSION: Remifentanil in high doses, as the single agent for patient preparation for awake fiberoptic intubation seems to improve intubating conditions, quality and reliability of the procedure. However, a higher incidence of recall is to be expected.

Use of remifentanil for awake fiberoptic intubation in a morbidly obese patient with severe inflammation of the neck.

Impending upper airway obstruction due to odontogenic facial and cervical spreading infection is a potential fatal situation that requires urgent treatment. In particular, securing the threatened airway is a priority and a precondition to the pressing need for surgery. The best approach to establish the difficult airway is awake fiberoptic intubation or scheduled tracheotomy under local anesthesia. We report a critical case of severe swelling of the neck in a morbidly obese patient with no alternative to awake fiberoptic intubation. The primary goals of optimal safety for the patient and appropriate intubating conditions for the anesthesiologist made us to consider a new method of patient medication.

[Indication and technique of orbital enlargement in the treatment of endocrine ophthalmopathy]. / Indikation und Technik der Orbitavergrösserung bei endokriner Orbitopathie.

Typical symptoms in endocrine ophthalmopathy are a result of an interstitial swelling of the ocular muscles and of the volume increase of the postbulbar fat and connective tissue. Clinically, we find a spectrum that reaches from infiltration of the eyelid and conjunctival tissue, exophthalmos, swelling of the muscles with diplopia, damage to the cornea till to involvement of the optic nerve with loss of vision. Regarding functional impairment of the optic nerve, orbital decompression represents an operative ultimate ratio. The surgical principle is based on the decompression within one or usually several orbital walls occasionally in combination with a sagittal enlargement of the eye socket by osteotomy and advancement of the orbital rims. As rule of thumb is considered: The reduction of the exophthalmos is proportional to the number of decompressed walls and amounts to 2-3 mm per decompressed orbital wall. A reduction of exophthalmos going beyond that can be obtained by advancement of the orbital rims.

Does liquid-based technology really improve detection of cervical neoplasia? A prospective, randomized trial comparing the ThinPrep Pap Test with the conventional Pap Test, including follow-up of HSIL cases.

OBJECTIVE: To compare the sensitivity, specificity and specimen adequacy of the ThinPrep Pap Test (TP) with the conventional Pap Test (CV) in a low-risk population with subsequent follow-up of HSIL cases. STUDY DESIGN: A prospective, randomized, controlled design was chosen to compare the TP with CV. Cytologic diagnosis and specimen adequacy were evaluated and compared with histology data in high grade squamous intraepithelial lesion (HSIL) cases. Fifteen gynecologists in private practice, all trained in colposcopy, participated in the trial. Cytologic diagnosis, specimen adequacy and follow-up of the cytologic HSIL cases were compared in the two groups. In total, 1,999 patients were included, 997 in the TP group and 1,002 in the CV group. Randomization assignments were designated on cytology case report forms, which were placed in sealed envelopes. Each envelope had a sequential randomization number on the outside to allow tracking and authentication of randomization assignments. RESULTS: Comparison of results between CVs and TPs revealed no statistically significant differences in all diagnostic categories, ranging from "within normal limits" to HSIL. Specimen adequacy, however, was superior with CVs (P < .001). The cytologic diagnosis of HSIL correlated with the histologic diagnosis in 91% of the TP group and 100% of the CV group. CONCLUSION: Because there was no statistically significant difference in sensitivity and specificity of the two techniques, improved detection of cervical abnormalities and better specimen adequacy might not be a consequence of utilizing liquid-based preparations but of a better sampling technique. Removing mucus and cellular debris from the cervical surface with a cellulose swab before sampling cells with a proper sampling device results in the same sensitivity and specimen adequacy and is much less expensive than the liquid-based technique.

Sampling, sampling errors and specimen preparation.

To obtain an adequate cervical smear for making a correct cytologic diagnosis, smear taking, laboratory handling and interpretation must be optimal. Many people are involved, and only by a combined effort of all links can this target be seriously approached: the smear takers will have to be open minded about technical improvements and read the morphologic descriptions cautiously; in the laboratory, cytotechnicians and physicians will have to challenge themselves and each other. It is mandatory to discard specimens that do not meet general standards of adequacy. At present a host of new techniques are being implemented. It is not feasible for all laboratories to be engaged in testing these new methods, but we are all requested to follow the development the best we can and switch to new ways when justified. Our working conditions are very different; therefore, it is our professional responsibility and plight to respond at the right time. So far the conclusion is that the conventional Pap smear is the international standard of care for the diagnosis of cervical cancer precursers in cancer screening programs. Certainly, this may change within a very short time. Liquid-based techniques, and in particular HPV technologies, are just around the corner.

[Absorbable and bioconvertible osteosynthesis materials in maxillofacial surgery]. / Resorbier- und umbaubare Osteosynthesematerialien in der Mund-, Kiefer- und Gesichtschirurgie.

In order to overcome the need for secondary intervention to remove metallic osteosynthesis devices after fracture healing, endeavours have been directed towards developing resorbable osteosynthesis materials during the last decade. The resorbable material must fulfil a number of basic demands. For example, an adequate holding strength of these materials is essential for undisturbed fracture union, complete resorption after bone healing, good histocompatibility without any damage to the surrounding tissues and without detrimental distant effects within the organism. Suggested materials are primarily high-polymerlactic acid or glycolic acid compounds. In particular, research was concentrated on the enhancement of the mechanical properties and biodegradation of polylactides. Debris high in crystallin was found to be responsible for late soft tissue reactions. To achieve disintegration products with lower crystallin content stereocopolymeres of lactic acids are preferred nowadays. Based on our experimental work, another osteosynthesis system manufactured from autoclaved allogenic bone tissue was developed as an alternative. This has osteoconductive properties and converts by creeping substitution into bone. In contrast to metallic plates and screws, the modulus of elasticity is quite similar to vital bone tissue. The initial strength enables its use in the field of maxillofacial surgery.

Osteosynthesis using biodegradable Poly-p-dioxanon (PDS II) in Le Fort I-osteotomy without postoperative intermaxillary fixation.

The purpose of the study was to evaluate the stability of Le Fort I advancement using biodegradable Poly-p-dioxanon (PDS II)-thread in the fixation of the osteotomy and to compare the results with that of metallic devices. Positional changes were registered by cephalometric examination with standardized radiography. 30 class III adult patients were chosen, whose treatment by surgical movement of the Le Fort I segment was similar in dimension and direction. They were subjected to a clinical and cephalometric analysis of postoperative stability. 4 lateral cephalometric X-rays were evaluated for each patient and compared in their two deviation levels. In order to assess the vertical and sagittal behaviour of the osteotomized segments, independent of intraoperatively altered structures, a system of coordinates was drawn up. Statistical examination of the existing data was carried out by computer. For calculation of significance the Wilcoxon-test, T-test, and Kruskal-Wallis-test were used. It could be demonstrated that PDS-thread as well as titanium-miniplates showed good stability in the anterioposterior plane, but a tendency to vertical relapse in both groups.