Augmentative antirotational plating provided a significantly higher union rate than exchanging reamed nailing in treatment for femoral shaft aseptic atrophic nonunion - retrospective cohort study.

BACKGROUND: Atrophic nonunion of femoral shaft fracture after intramedullary (IM) nailing is uncommon. The treatment for femoral shaft aseptic atrophic non-union remained controversial. The aim of this study was to compare the surgical results between exchanging reamed nailing (ERN) and augmentative antirotational plating (AAP) for femoral shaft aseptic atrophic nonunion. METHODS: We retrospectively reviewed the patients with femoral shaft nonunion between the year of 2014 and 2015. The patients with nonunion after plate osteosynthesis, septic nonunion, hypertrophic nonunion, additional surgery during revision surgery were excluded. All the patients were followed up at least 12 months. RESULTS: Overall, the union rate after revision surgery was 70.8%. The union rate was significantly higher in the AAP group than in the ERN group. Operating time was also significantly shorter in the AAP group. Regarding the location of nonunion, the union rate was comparable between groups for isthmic nonunions. However, for non-isthmic nonunions, the union rate was significantly higher and operating time was significantly shorter in the AAP group. CONCLUSION: AAP showed an overall higher union rate for management of femoral shaft aseptic atrophic nonunion compared with ERN. Especially for non-isthmic femoral shaft atrophic nonunions, AAP provided a significantly higher union rate and significantly shorter operating time.

Microbiological performance of a robotic system for aseptic compounding of cytostatic drugs.

BACKGROUND: Compounding of cytostatic drugs requires strict aseptic procedures, while exposure to toxic drugs and repetitive manual movements should be minimized. Furthermore, reuse of vials is desirable to lower the costs. To assess if all this might be safely achieved with a robot, this study aimed at qualifying the aseptic preparation process with the robotic system APOTECAchemo. METHODS: The aseptic compounding of patient-individual cytostatic solutions was simulated with media fill simulation tests to qualify the performance according to European GMP Annex 1. The contamination in the environment was measured in critical places using settle plates, contact plates, active air sampling and particle counting. Media-fill simulation tests were prepared in 3 production batches. The second part of the study evaluated the microbiological shelf-life of commercial drug vials after repeated puncturing. On six days, fifty syringes of 15 ml media were prepared from the same 50 vials with the robot. After each preparation, vials were covered with an IVA seal upon unloading from the robot to protect them from microbiological contamination. RESULTS: No microbiological contamination was found in any of the 96 media fill preparations, nor in any of the 300 syringes that were prepared with repeated puncturing. The compounding area met class A limits, while class A criteria were not fulfilled by the contact plates and settle plates placed on the right side of the loading area. There, the average colony forming units (cfu) were 3 and 1.17, respectively, meeting class B criteria. CONCLUSIONS: Robotical compounding of cytostatic drugs with APOTECAchemo meets the microbiological requirements of the European GMP. In addition, the robot can reuse vials repeatedly and safely, thereby enabling extended usage.

What should we expect from the hybrid room?

The concept of hybrid room was defined as an optimized surgical theater, offering the best compromise between asepsis criteria from standard surgical rooms and high quality imaging equipment from fixed radiological suites. This review aimed at summarizing what vascular surgeons should expect from hybrid rooms in daily practice and in the near future.

How does closed system vitrification of human oocytes affect the clinical outcome? A prospective, observational, cohort, noninferiority trial in an oocyte donation program.

OBJECTIVE: To evaluate whether is possible to vitrify oocytes in an aseptic (hermetically closed) fashion and maintain clinical results comparable with those of fresh oocytes. DESIGN: Prospective, observational, cohort, noninferiority trial. SETTING: Private in vitro fertilization center. PATIENT(S): One hundred eighty-four recipients of donated vitrified oocytes. INTERVENTION(S): Closed system vitrification. MAIN OUTCOME MEASURE(S): Pregnancy rate per cycle and clinical pregnancy rate per cycle. RESULT(S): No statistically significant differences were observed between two groups regarding the pregnancy rate per cycle (63.1% vs. 60.9%) or the clinical pregnancy rate per cycle (55.4% vs. 58.7%). Biochemical pregnancy rate was statistically significantly higher in the fresh group (7.6% vs. 2.2%). The mean number of embryos transferred was similar (2.0 ± 0.0 vs. 1.97 ± 0.3). Concerning embryologic data, there were no statistically significant differences regarding the fertilization, cleavage, top quality day-3 embryo, or blastocyst rates, whereas the top quality blastocyst rate on day 5 was statistically significantly higher in the fresh oocyte group (31.7% vs. 26.1%). CONCLUSION(S): Aseptically (in a closed system) vitrified oocytes show similar clinical efficiency compared with their sibling fresh oocytes.

Choosing a Vial Processing Line for Aseptic Compounding: Part 1.

Equipment systems that enable compliance with stringent state and federal compounding requirements are a topic of increasing interest to U.S. pharmacists. Of those equipment types, an aseptic vial processing line offers unique benefits (especially to 503B compounding pharmacies and small contract manufacturers of aseptic pilot-size batches) if the volume of sterile preparations dispensed offsets the cost of purchase, installation, and maintenance. In this article, the reasons for and the process of selecting an aseptic vial processing line for use in 2 independent 503B compounding pharmacies are presented, the operation of our choice of equipment is described, and specifications for the components of that line are listed. In part 2 of this series, the success of our choice and its effect on sterile compounding in our facilities will be reported.

[FIXING DEVICE FOR CLOSING AND COUPLING AN INTRAVENOUS CATHETER]. / DISPOSITIVO DE FIJACIÓN, CIERRE Y ACOPLAMIENTO PARA CATÉTER DE PERFUSIÓN INTRAVENOSA.

INTRODUCTION: skin fixing devices in peripheral, central or arterial catheters have several important drawbacks: site infection, stacking of material in the anatomical area which is very annoying for the patient and medical staff risk when fixating stitches are used. OBJECTIVE: to develop a fixing device that simplifies presently used systems, favoring asepsis and motility. METHODS: the device herein described is composed by a mechanical fixation, a closing system and coupling for intravenous catheters. The system has a thin circular piece with at least two holes for subcutaneous fixation, one or several conducts for lumina and a hollow cylindrical part in one side, screwed exteriorly and flat inside, with an oriented protuberance. A watertight plug with one or several thin tubes that adapt to the lumina, a positional slot, a handle and a solid screwed tap for perfect closure are available for at home use. An intermediate plug with one or several lumina and a screwed hollow plug are provided for in hospital use. RESULTS: the above described device is intended to be used in two settings: in hospital and at home. It is supposed to reduce the risk of infection and stacking of the anatomical site where cutaneo us puncture with fixation of peripheral, central or arterial catheters is performed.

Introducción: los medios de fijación a la piel de un catéter venoso periférico, de un catéter venoso central o de un catéter arterial central presentan los siguientes graves inconvenientes: ser la sede de infecciones a nivel del lugar de la punción, provocar una saturación de la zona anatómica, la cual resulta muy difícil de soportar e incómodo para el paciente portador, y suponer un riesgo para el personal de enfermería cuando se usan hilos de sutura para fijar el soporte del catéter. Objetivo: por lo anteriormente expuesto, se ha detectado la necesidad de diseñar un dispositivo que reduzca la complejidad y aparatosidad de los sistemas conocidos y empleados en la actualidad, favoreciendo la asepsia y la movilidad del paciente. Método: el desarrollo presentado en este artículo se refiere a un sistema mecánico de fijación, cierre y acoplamiento para catéter de perfusión intravenosa. El sistema dispone de una pieza circular de pequeño espesor con al menos dos orificios para su fijación subcutánea, centralmente de uno o más conductos para acoplar lúmenes, y de una parte cilíndrica hueca que sobresale a uno de los lados, exteriormente roscada e interiormente lisa con un tetón de posición. Para uso domiciliario se dispone de un tapón de estanqueidad con uno o más tubos de pequeño diámetro que se acoplan en los orificios para lúmenes, una ranura de posición, un tirador y un tapón roscado ciego para el cierre hermético con la parte roscada. Para uso hospitalario se dispone de un tapón intermedio con una o más entradas para lúmenes, así como de un tapón roscado hueco que permite su acoplamiento hermético con la parte roscada. Resultados: el desarrollo descrito en este artículo va a ser utilizado en dos ambientes: ambiente domiciliario y ambiente hospitalario. Además, reduce el riesgo de infección y saturación de la zona anatómica de los pacientes en los que se realiza la punción cutánea en la que se fijan catéteres venosos periféricos, catéteres venosos centrales o catéteres arteriales centrales.

Inyección preauricular de betametasona de depósito y aciclovir para el tratamiento del herpes zóster oftálmico agudo / Preauricular injection of betamethasone depot and acyclovir for the treatment of acute herpes zoster ophthalmicus

CASOS CLÍNICOS: Para el manejo del herpes zóster oftálmico (HZO), se han descrito diferentes tratamientos. Sin embargo, la evolución de estos pacientes es usualmente prolongada y muchos de ellos desarrollan neuritis postherpética (NPH). En el presente trabajo, se presentan 3 casos clínicos, en los cuales, mediante una inyección preauricular de una mezcla de betametasona de depósito combinada con aciclovir se obtuvo una importante mejoría clínica y sintomática. Adicionalmente, no se reportó el desarrollo de NPH. DISCUSIÓN: La inyección preauricular de betametasona de depósito y aciclovir podría constituir una buena alternativa para el manejo del HZO

CLINICAL CASES: Several treatments have been described for the management of patients with herpes zoster ophthalmicus (HZO). However, the progress of these patients is usually slow, and many of them develop postherpetic neuritis (PHN). In the present paper, three clinical cases are presented, in which a significant symptomatic improvement was obtained by using a preauricular injection of a mixture of betamethasone depot combined with acyclovir. PHN did not develop in any of them. DISCUSSION: The preauricular injection of betamethasone depot and acyclovir could be a good alternative for the management of HZO

Negotiating technologies in surgery: the controversy about surgical gloves in the 1890s.

This article examines the controversial discussions about surgical gloves in the German-language countries in the 1890s. Analyzing the controversy as a contradiction between two important strategies of modern surgery, manual control and aseptic control, it looks at the various ways surgeons dealt with the conflict. Most important, they tried to resolve the problem by designing gloves that reconciled the two conflicting control strategies. This perspective helps to better understand the lengthy process of negotiation and the detailed discussions in the decades before surgical gloves became a standard element of modern operating equipment.

Hemocultivos... ¿Qué te han contado y qué haces? / Blood cultures... What they tell you and what you do

Objetivo: Objetivo principal: Conocer la variabilidad práctica de los enfermeros/as (DUE's) del Hospital General Nuestra Señora del Prado, sobre la técnica para la extracción de hemocultivo. Objetivos específicos: Determinar las condiciones de asepsia/ esterilidad de la técnica. Establecer la utilización (desinfección, orden de llenado, volumen, cambio de aguja) de los frascos de hemocultivos. Método: Estudio descriptivo transversal realizado en el Hospital General Nuestra Señora del Prado. Ha consistido en la entrega de un cuestionario para autocumplimentación a los profesionales de enfermería, donde se han incluido variantes tanto cuantitativas como cualitativas. Resultados: Se han recogido 52,9% encuestas de los 363 DUE's del centro hospitalario, con una experiencia profesional media de 12,9 años [DE±7,9]. El 57,8% cree que no es necesario técnica estéril para el procedimiento. 94,7% utiliza un único antiséptico. 78,6% afirman que en la extracción de acceso venoso central desecha los primeros 10cc que extrae. Conclusiones: Consideramos un alto índice de respuesta, ya que es superior al 40% para cuestionarios autocumplimentados. Hemos observado que la mayoría de DUE's utilizan técnica aséptica y en los protocolos estudiados no existe un consenso entre la utilización de técnica estéril y aséptica. Este estudio nos revela que la mayoría de los DUE's utilizan un único antiséptico, sin embargo la mayoría de los protocolos recomiendan la utilización primero de alcohol y luego povidona yodada para la desinfección de la piel (AU)

Aims: Main aim: To ascertain differences in nurses at the Hospital General Nuestra Señora del Prado, in blood extraction and blood culture techniques. Specific aims: To determine the asepsis/sterility conditions of the technique; to establish the use (disinfection, filling order, volume, needle change) of the blood culture vials. Method: Transversal descriptive study made at the Hospital General Nuestra Señora del Prado. A self-completion questionnaire including quantitative and qualitative variants was delivered to nursing professionals. Results: 52.9% of the questionnaires were collected from the 363 DUE's at the hospital. Mena working experience was 12.9 years [DE±7,9]. 57,8% believe sterile technique for the procedure was not necessary. 94.7% use a single antiseptic. 78.6% stated that they discard the first 10 cc extracted from the central vein. Conclusions: We consider that the response is high, with over 40% of the questionnaires being completed. We observed that most DUE's use aseptic techniques and in the protocols studied there was no consensus about the use of sterilization and septic techniques. The study reveals that the majority of the DUE's use a single antiseptic, even though most protocols recommend the use of alcohol, followed by povidone.iodine to disinfect the skin (AU)

Teaching aseptic technique for central venous access under ultrasound guidance: a randomized trial comparing didactic training alone to didactic plus simulation-based training.

BACKGROUND: Our goal was to determine whether simulation combined with didactic training improves sterile technique during ultrasound (US)-guided central venous catheter (CVC) insertion compared with didactic training alone among novices. We hypothesized that novices who receive combined didactic and simulation-based training would perform similarly to experienced residents in aseptic technique, knowledge, and perception of comfort during US-guided CVC insertion on a simulator. METHODS: Seventy-two subjects were enrolled in a randomized, controlled trial of an educational intervention. Fifty-four novices were randomized into either the didactic group or the simulation combined with didactic group. Both groups received didactic training but the simulation combined with didactic group also received simulation-based CVC insertion training. Both groups were tested by demonstrating US-guided CVC insertion on a simulator. Aseptic technique was scored on 8 steps as "yes/no" and also using a 7-point Likert scale with 7 being "excellent technique" by a rater blinded to subject randomization. After initial testing, the didactic group was offered simulation-based training and retesting. Both groups also took a pre- and posttraining test of knowledge and rated their comfort with US and CVC insertion pre- and posttraining on a 5-point Likert scale. Subsequently, 18 experienced residents also took the test of knowledge, rated their comfort level, and were scored while performing aseptic US-guided CVC insertion using a simulator. RESULTS: The simulation combined with didactic group achieved a 167% (95% confidence interval [CI] 133%-167%) incremental increase in yes/no scores and 115% (CI 112%-127%) incremental increase in Likert scale ratings on aseptic technique compared with novices in the didactic group. Compared with experienced residents, simulation combined with didactic trained novices achieved an increase in aseptic scores with a 33.3% (CI 16.7%-50%) increase in yes/no ratings and a 20% (CI 13.3%-40%) increase in Likert scaled ratings, and scored 2.5-fold higher on the test of knowledge. There was a 3-fold increase in knowledge and 2-fold increase in comfort level among all novices (P < 0.001) after combined didactic and simulation-based training. CONCLUSION: Simulation combined with didactic training is superior to didactic training alone for acquisition of clinical skills such as US-guided CVC insertion. After combined didactic and simulation-based training, novices can outperform experienced residents in aseptic technique as well as in measurements of knowledge.

Effect of needle size and type, reuse of needles, insertion speed, and removal of hair on contamination of joints with tissue debris and hair after arthrocentesis.

OBJECTIVE: To assess joint contamination with tissue and hair after arthrocentesis of equine fetlock joints. STUDY DESIGN: Experimental. ANIMALS: Limb specimens from 8 equine cadavers. PROCEDURES: Soft tissues including the joint capsule were harvested from the dorsal aspect of the fetlock joints and mounted on a wooden frame. Needles inserted through the joint tissue preparation were flushed into tissue culture plates that were examined for tissue and hair debris. Variables evaluated were gauge and type of needle (16, 18, 20, and 22 G sharp disposable needles and 20 G disposable spinal needles with stylet), number of times each needle was used (1, 2, 3, 4), length of hair (unclipped, clipped, shaved with razor), and needle insertion speed (fast, slow). Descriptive and statistical evaluations were performed. RESULTS: Tissue contamination was identified in 1145 of 1260 wells and hair contamination was identified in 384 of 1260 wells. Twenty gauge needles inserted through unclipped hair resulted in the least amount of hair contamination. Compared with 20 G needles with fast insertion 1 time through unclipped hair the odds ratios for contamination with hair were significantly greater for 16 G sharp disposable needles, 20 G spinal needles, clipped hair, shaved hair, and reuse of the needles. Spinal needles inserted through unclipped hair transferred many long hairs into the joint space. CONCLUSION: Reuse of needles for arthrocentesis should be avoided. Removal of hair is not indicated for arthrocentesis with sharp injection needles but is recommended when using spinal needles with stylets. CLINICAL RELEVANCE: Joint contamination with hair and tissue debris will be decreased by specific needle insertion techniques. Decreased contamination of joints may reduce the frequency of joint infections after arthrocentesis.

Efficacy of soaking in 70% isopropyl alcohol on aerobic bacterial decontamination of surgical instruments and gloves for serial mouse laparotomies.

Rodent surgeries in biomedical research facilities are often performed in series. This practice presents many challenges to maintaining aseptic technique between animals. Here, we examined using soaking in 70% isopropyl alcohol for aerobic bacterial decontamination of surgical instruments and gloves used in a series of as many as 10 mouse laparotomy surgeries. These surgeries were performed on mice that were euthanized immediately prior to the procedure. Instruments and gloves were cultured before and after each procedure to determine the presence of aerobic bacterial contamination. To assess the efficacy of the decontamination protocol, culture results were grouped by procedure and then paired (before soak and after soak) for analysis using McNemar test at an α level of 0.05. In addition, by using the Fisher exact test, this modified aseptic method was compared with strict aseptic technique, for which autoclaved instruments and sterile surgical gloves were used for each procedure. In this study, we observed that the modified aseptic technique using 70% isopropyl alcohol soaks pre- vented aerobic bacterial contamination of instruments and gloves for as many as 5 mice.

El sondaje vesical en pediatría ¿puede dar complicaciones?. El caso de la Cistografía Ureteral Miccional Seriada / Can Bladder Catheterization in Pediatrics Cause Complications?. The case of a urethral dysuria cystograph

La CUMS (Cistografía Ureteral Miccional Seriada) es el primer procedimiento diagnóstico, por rayos X, para la evaluación del reflujo vesicoureteral. Consiste en un sondaje vesical para administrar un contraste radiopaco a través de la uretra. Realizar dicha técnica sin unas medidas de asepsia y sin conocimientos de la misma puede dar lugar a posibles complicaciones. Mediante un estudio retrospectivo, con una muestra de 181 pacientes, se ha valorado la incidencia de posibles complicaciones y/o molestias posteriores a una CUMS. Como resultados finales, a través de una llamada telefónica tras la prueba, se ha observado que en el 96,7% de los niños no se ha manifestado ningún tipo de complicación, ni molestia urinaria(AU)

A urethral dysuria cystograph (CUMS ( Cistografia Ureteral Miccional Seriada)) is the first diagnostic procedure, by means of x-rays, to evaluate bladder-urethral reflux. It consists of a bladder catheter to administer a radiopaque contrast dye through the ureter. To use the aforementioned technique without any asepsis measures and without knowledge about it can lead to possible complications. By means of a retrospective study, using a sample of 181 patients, the authors have evaluated the incidence of possible complications and/or subsequent discomfort due to a urethral dysuria cystograph (CUMS). As final results, by means of an after test telephone call, the authors observed that 96.7% of the children who underwent this technique did not manifest any type of complication nor urinary discomfort(AU)

Manejo del drenaje recuperador y autotransfusor de sangre tipo Bellovac ABT / Handling of a Bellovac ABT drainage recuperation-blood auto transfusion device

Se exponen las características del drenaje recuperador-autotransfusor de sangre tipo Bellovac ABT, así como su manejo adecuado y los cuidados de enfermería requeridos con el fin de minimizar los riesgos y proporcionar una óptima seguridad al paciente. También se exponen las complicaciones potenciales y se discuten las principales ventajas e incovenientes de este tipo de drenaje(AU)

The authors describe the characteristics of the Bellovac ABT drainage recuperation - blod auto transfusion device along with its proper handling and the required nurses´ care in order to minimize the risks and to provide optimun safety for patients. The authors also explain the potential complications and they discuss the main advantages this type of drainage has(AU)

Some observations on airborne particles in the critical areas of a blow-fill-seal machine.

Regulatory authorities set requirements on factors such as maximum allowed airborne particle concentrations in critical areas and the surrounded environment. An important issue when producing sterile drugs by aseptic processing with blow-fill-seal technology is to achieve Class 100 (ISO Class 5) in the critical area. To meet these requirements high efficiency particulate air (HEPA)-filtered airflow is used to dilute and remove airborne particles. The required airflow is dependent on the quantity of generated particles. The purpose of this paper is to present the measures taken to reduce airborne particle concentrations at critical areas of a blow-fill-seal machine. The methods being used in the experimental studies are smoke visualization and particle measurements. The results show that particle concentrations can be reduced by minor changes of process variables. By changing the process variables, particle concentrations--number of particles (> or = 0.5 microm) per cubic foot--in the shroud (filling zone), extrusion zone, and the filling room were approximately reduced as follows: approximately 90% in the shroud (filling zone), approximately 90% in the extrusion zone, and approximately 40-60% in the filling room. It should be noted that the presented results are limited to one type of blow-fill-seal machine and this paper is a continuation of an earlier published paper by the authors in the PDA

Sterile versus non-sterile glove use and aseptic technique.

There is evidence indicating that improvements in infection control practice can reduce the incidence of healthcare-associated infection. This article explores the evidence base for glove use and aseptic technique. There is a lack of evidence regarding the influence of sterile versus clean gloves in clinical care. Therefore in practice, clean and aseptic techniques are often used interchangeably. Nurses must learn to select clean or aseptic technique, and therefore clean or sterile gloves, using a risk assessment protocol. Regular audits of aseptic technique and education are needed to improve care.

CFD modeling of pharmaceutical isolators with experimental verification of airflow.

Computational fluid dynamics (CFD) models have been developed to predict the airflow in a transfer isolator using a commercial CFD code. In order to assess the ability of the CFD approach in predicting the flow inside an isolator, hot wire anemometry measurements and a novel experimental flow visualization technique consisting of helium-filled glycerin bubbles were used. The results obtained have been shown to agree well with the experiments and show that CFD can be used to model barrier systems and isolators with practical fidelity. This indicates that CFD can and should be used to support the design, testing, and operation of barrier systems and isolators.