Image-based non-invasive assessment of suction blister wounds for clinical safety and efficacy.

Recognising the need for objective imaging-based technologies to assess wound healing in clinical studies, the suction blister wound model offers an easily accessible wound model that creates reproducible epidermal wounds that heal without scarring. This study provides a comprehensive methodology for implementing and evaluating photography-based imaging techniques utilising the suction blister wound model. Our method encompasses a protocol for capturing consistent, high-quality photographs and procedures for quantifying these images via a visual wound healing score and a computer-assisted colour analysis of wound exudation and wound redness. We employed this methodology on 16 suction blister wounds used as controls in a clinical phase-1 trial. Our method enabled us to discern and quantify subtle differences between individual wounds concerning healing progress, erythema and wound exudation. The wound healing score exhibited a high inter-rater agreement. There was a robust correlation between the spectrophotometer-measured erythema index and photography-based wound redness, as well as between dressing protein content and photography-based dressing yellowness. In conclusion, this study equips researchers conducting clinical wound studies with reproducible methods that may support future wound research and aid in the development of new treatments.

Research on the effect of environmental regulation to the green water resource efficiency in China-based on the perspectives of high pressure and low suction.

Environmental regulation with spatial spillover effect is an important way to accelerate the transformation and upgrading of modern water resources structure, and then achieve sustainable development of China's water resources. How does environmental regulation affect the GWRE to alleviate or solve China's water shortage? In this paper, the GWRE is measured based on panel data from 31 provinces in China from 2000-2020, and the impact of high pressure (low suction) and heterogeneity on GWRE by environmental regulations is explored. The results revealed that the high pressure of environmental regulation significantly promoted the improvement of GWRE, but the improvement effect of low suction power was not significant. Similar conclusions are drawn under the tests of population size-economic distance and population size-technology distance. The high pressure of market-type and autonomous-type environmental regulation has a significant effect on GWRE, while the improvement effect of command-type environmental regulation is weak. The high pressure of environmental regulation in the eastern, central, western, and northeastern regions has a decreasing effect on GWRE. It is recommended to break the principle of GDP performance appraisal, establish and improve the "green performance" evaluation system, adopt regional differentiated environmental regulation policies, and establish a modern green water resources industrial structure system.

Eficacia y seguridad del drenaje endoscópico transmural en pacientes con colecciones líquidas pancreáticas sintomáticas no tributarios a drenaje endoscópico transpapilar / Efficacy and safety of transmural endoscopic drainage in patients with symptomatic pancreatic fluid collections not amenable to transpapillary endoscopic drainage

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021 y ampliada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 97-IETSI-ESSALUD2022, se ha elaborado el presente dictamen sobre la evaluación de la eficacia y seguridad del drenaje endoscópico transmural en pacientes con colecciones líquidas pancreáticas (CLP) sintomáticas no tributarios a drenaje endoscópico transpapilar. ASPECTOS GENERALES Los aspectos relacionados con la epidemiología, etiología, clasificación, y sintomatología de las CLP han sido previamente detallados en el Dictamen Preliminar de Evaluación de Tecnología Sanitaria N° 002-DETS-IETSI-2021 Eficacia y Seguridad del drenaje endoscópico con prótesis LAMS en pacientes adultos con colecciones líquidas pancreáticas sintomáticas (Instituto de Evaluación de Tecnologías en Salud e Investigación 2021). 3 Tipo de drenaje realizado a partir de la colocación de un stent a nivel de la papila (ampolla de Vater). Este sitio anatómico se encuentra posicionado en la unión entre el conducto biliar y el conducto pancreático, y es donde se produce el vaciamiento de la bilis y enzimas digestivas hacia el intestino delgado. El drenaje de las CLP sintomáticas puede ser realizado mediante los abordajes quirúrgico, percutáneo y endoscópico (Mahapatra and Garg 2019). Sin embargo, los especialistas solicitantes de la institución, señalan que el abordaje endoscópico podría ofrecer un mejor balance riesgo beneficio, con menor tiempo de recuperación, y menor tasa de complicaciones relacionadas, al ser un método menos invasivo que los procedimientos de drenaje quirúrgico y percutáneo. El drenaje endoscópico puede ser realizado por vía transmural o transpapilar3, o una combinación de ambas; sin embargo, la aplicación del drenaje transpapilar requiere que exista comunicación entre la CLP y el conducto pancreático principal, lo cual no ocurre en todos los casos (Tan et al. 2021). Así, en escenarios donde el drenaje transpapilar, ya sea de forma individual o combinada, no es posible, se puede optar por el drenaje de tipo transmural. METODOLOGÍA: Se llevó a cabo una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia sobre la eficacia y seguridad del drenaje endoscópico transmural en pacientes con CLP sintomáticas no tributarios a drenaje endoscópico transpapilar. La búsqueda bibliográfica se realizó en las bases de datos PubMed, The Cochrane Library. Web of Science y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan ETS y G PC, incluyendo el IETSI, Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), la Agency for Healthcare Research and Quality's (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), Comissáo Nacional de Incorporaóáo de Tecnologias no Sistema Único de Saúde (CONITEC), Instituto de Evaluación Tecnológica en Salud (IETS), Instituto de Efectividad Clínica y Sanitaria (IECS), Scottish Medicines Consortium (SMC), Canadian Agency for Drugs and Technologies in Health (CADTH), Instituto de Calidad y Eficiencia en la Atención de la Salud (lOWiG, por sus siglas en alemán), y Hauté Autorité de Santé (HAS). Además, se realizó una búsqueda de GPC en las páginas web de las principales t\sociedades o instituciones especializadas el manejo de patologías de la cavidad .11 abdominal y gastrointestinales, tales como: European Society of Gastrointestinal . Endoscopy (ESGE), American College of Gastroenterology (ACG), World Gastroenterology Organisation (WGO), y la American Society for Gastrointestinal Endoscopy (ASGE). Finalmente, se realizó una búsqueda en las páginas web de ClinicalTrials.govy la International Clinical Trials Registry Platform, en busca de estudios clínicos en curso o aún no publicados. RESULTADOS: Luego de la búsqueda bibliográfica con fecha 07 de julio del 2022, se incluyeron cuatro GPC, y tres E0. Las GPC incluidas fueron elaboradas por: la Korean Society of Gastrointestinal Endoscopy (KSGE), la Society of Gastrointestinal Endoscopy of India/Indian Endoscopic Ultrasound Club (SGEI/EUS Club), y la European Society of Gastrointestinal Endoscopy (ESGE) (Shah et al. 2021, Oh et al. 2021, Arvanitakis et al. 2018, Dumonceau et al. 2019). Finalmente, se incluyeron tres EO comparativos: Kumar et al. 2014 (Kumar, Conwell, and Thompson 2014), Keane et al. 2016 (Keane et al. 2016), y Tan et al. 2018 (Tan et al. 2018). No se identificaron ETS, revisiones sistemáticas (RS) con o sin metanálisis (MA), ni ECA que cumplieran con los criterios de inclusión para la presente evaluación. CONCLUSIÓN: Por todo lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación aprueba la incorporación del drenaje endoscópico transmural como procedimiento, para su uso en pacientes adultos con necrosis amuralladas sintomáticas, no tributarios a drenaje endoscópico transpapilar. Cabe señalar que, para poder utilizar este procedimiento en la institución, se requiere de la evaluación previa de la eficacia y seguridad comparativa de los dispositivos que permiten la aplicación del drenaje transmural, para determinar técnicamente cual sería la que ofrece el mayor beneficio clínico para la población de interés. En cuanto a la población de pacientes con pseudoquistes pancreáticos sintomáticos, no tributarios a drenaje transpapilar, no se aprueba el uso de drenaje transmural, debido a que, no se identificaron argumentos técnicos suficientes para sustentar su uso en estos pacientes.

Rectal suction biopsies to diagnose Hirschsprung's disease in a low-resource environment - optimising cost-effectiveness.

BACKGROUND: The diagnosis of Hirschsprung's disease (HD) by rectal suction biopsy (RSB) has cost implications that could be reduced by ascertaining the optimal number of specimens required. The aim was to audit our experience to optimise cost-effectiveness. METHODS: Medical records of all patients who underwent an RSB between January 2018 and December 2021 were reviewed. In 2020, we transitioned from using the Solo-RBT to the rbi2 system (requiring single-use cartridges). Descriptive statistics were reported and a comparative analysis of the diagnostic efficacy of the Solo-RBT versus the rbi2 system was performed. The cost of consumables was calculated according to the number of specimens submitted. RESULTS: Of 218 RSBs, 181 were first and 37 were repeat. The mean age at biopsy was 62 days (IQR 22-65). An average of two tissue specimens were obtained per biopsy. Of the 181 first biopsies, 151 were optimal and 30 suboptimal. HD was confirmed in 19 (10.5%) of the patients. Amongst biopsies where a single specimen was obtained, 16% were inconclusive, compared to 14% with two specimens and 5% with three specimens. The cartridges for the rbi2 system cost R530. If two cartridges are used at initial biopsy the total cost is double of a single tissue specimen sent for initial biopsy, and two specimens sent for repeat biopsies. CONCLUSION: In a low-resource setting, selecting the appropriate RSB system and obtaining a single specimen is sufficient to diagnose HD. Patients with inconclusive results should undergo a repeat biopsy where two specimens are obtained.

Assessment of the biometric modifications of the eye in LASIK during suction.

PURPOSE: To study the biometric modifications of the eyeball during suction in Laser assisted in Situ Keratomileusis (LASIK). METHODS: Observational and cross-sectional study. We studied 43 patients who underwent surgery for myopia and myopic astigmatism. Mean age was 38.3 ±â€¯11.5 years, and 19 were female (44.2%). Conventional LASIK surgery with a manual microkeratome was performed. Before and during the suction maneuvre the following parameters were measured using an 11 Mhz biometric probe: aqueous depth (AQD), lens thickness (LT), vitreous cavity length (VCL) and axial length (AXL). Paired t-test was used to compare the biometric measurements before and during suction. RESULTS: The mean spherical equivalent refractive error was -4.5 ±â€¯2.3 diopters. During suction, the AQD did not change significantly (p = 0.231). However, AXL and VCL increased by 0.12 mm and 0.22 mm respectively (p = 0.039 and <0.01) and LT decreased by 0.20 mm (p < 0.01). AXL increased in 42% of the eyes and decreased in 16%, VCL increased in 70% of the eyes and decreased in 9%, and the LT was reduced in 67% of the eyes. CONCLUSIONS: Suction maneuvres during LASIK surgery produce changes of little magnitude in the eye globe, mainly a decrease in LT and an increase in VCL and AXL. Therefore, these modifications are expected to produce minimal anatomic alterations.

Preclinical safety assessment of the suction-assisted intradermal injection of the SARS-CoV-2 DNA vaccine candidate pGO-1002 in white rabbit.

pGO-1002, a non-viral DNA vaccine that expresses both spike and ORF3a antigens of SARS-CoV-2, is undergoing phase 1 and phase 2a clinical trials in Korea and the US. A preclinical repeated-dose toxicity study in New Zealand white rabbits in compliance with Good Laboratory Practice (GLP) was conducted to assess the potential toxicity, local tolerance, and immunogenicity of the vaccine and GeneDerm suction device. The dose rate was 1.2 mg/head pGO-1002, and this was administered intradermally to a group of animals (eight animals/sex/group) three times at 2-week intervals, followed by a 4-week recovery period. After each administration, suction was applied to the injection site using the GeneDerm device. Mortality, clinical signs, body weight, food consumption, skin irritation, ophthalmology, body temperature, urinalysis, and clinical pathology were also monitored. Gross observations and histopathological evaluation were performed. Overall, pGO-1002 administration-related changes were confined to minor damage or changes at the injection site, increased spleen weight and minimal increased cellularity in white pulp. All changes of injection site were considered local inflammatory changes or pharmacological actions due to the vaccine with the changes in spleen considered consistent with vaccine-induced immune activation. All findings showed reversibility during the 4-week recovery period. Animals vaccinated with pGO-1002, administered by intradermal injection and followed by application of suction with GeneDerm, developed humoral and cellular responses against the SARS-CoV-2 antigens consistent with prior studies in rats. Collectively, it was concluded that the pGO-1002 vaccine was safe and effective under these experimental conditions and these data supported future human study of the vaccine, now known as GLS-5310, for clinical trial use.

Investimentos do Sistema Único de Saúde em avaliação miofuncional do sistema estomatognático / Investments of the Single Health System in myofunctional assessment of the stomatognatic system

Introdução: o sistema estomatognático é responsável por funções inatas e primordiais ao ser humano, como respiração, sucção, deglutição e fonação. O fonoaudiólogo é o profissional qualificado para realizar avaliação, diagnóstico e reabilitação desse sistema. Dessa forma, tais procedimentos são realizados por serviços de fonoaudiologia, e essa produtividade é lançada na plataforma correspondente do Sistema Único de Saúde (SUS) como "avaliação miofuncional do sistema estomatognático". Objetivo: analisar os investimentos do SUS destinados à avaliação miofuncional do sistema estomatognático no Brasil, no período de 2008 a 2021. Metodologia: trata-se de estudo ecológico, de caráter quantitativo, realizado com dados secundários disponibilizados na plataforma DataSUS/TABNet. Os dados coletados se referem a valores apresentados e aprovados para a avaliação miofuncional do sistema estomatognático, no período supracitado, no Brasil. Após a coleta, realizou-se a análise descritiva dos dados, com exposição dos valores absolutos e relativos, das taxas de crescimento e do déficit de repasses dos recursos financeiros. Resultados: no período estudado, foram realizadas 5,4 milhões de avaliações miofuncionais do sistema estomatognático, a um custo total de R$ 21,5 milhões com taxas de crescimento dos investimentos financeiros de até 64,1% ao longo dos anos. Observou-se que, em todo o período estudado, ocorreu déficit de repasses para procedimentos relacionados aos serviços de fonoaudiologia, chegando a taxas de 17464,6% de pagamentos não efetuados. Conclusão: constatou-se que houve aumento dos investimentos financeiros do SUS destinados ao procedimento de avaliação miofuncional. Contudo, foram notados, também, déficits de pagamentos pelas secretarias de saúde, destinados a uma parcela dos procedimentos realizados nos serviços de fonoaudiologia.

Introduction: the stomatognathic system is responsible for innate and primordial functions for human beings, such as breathing, sucking, swallowing and phonation. The speech therapist is the qualified professional to carry out evaluation, diagnosis and rehabilitation of this system. Thus, such procedures are performed by speech therapy services, and this productivity is released on the corresponding platform of the Unified Health System (SUS) as "myofunctional assessment of the stomatognathic system". Objective: to analyze SUS investments for the myofunctional assessment of the stomatognathic system in Brazil, from 2008 to 2021. Methodology: this is an ecological study, of a quantitative nature, carried out with secondary data available on the DataSUS/TABNet platform. The data collected refer to values presented and approved for the myofunctional assessment of the stomatognathic system, in the aforementioned period, in Brazil. After collection, a descriptive analysis of the data was carried out, with exposure of absolute and relative values, growth rates and the deficit in transfers of financial resources. Results: in the studied period, 5.4 million myofunctional assessments of the stomatognathic system were performed, at a total cost of R$ 21.5 million, with growth rates of financial investments of up to 64.1% over the years. It was observed that, throughout the studied period, there was a deficit in transfers for procedures related to speech therapy services, reaching rates of 17464.6% of payments not made. Conclusion: it was found that there was an increase in SUS financial investments for the myofunctional assessment procedure. However, deficits in payments by the health secretariats were also noted, destined for a portion of the procedures performed in the speech-language pathology services.

Assessment of PFAS in collocated soil and porewater samples at an AFFF-impacted source zone: Field-scale validation of suction lysimeters.

Per- and polyfluoroalkyl substances (PFAS) measurable in soil porewater authoritatively represent the mobile mass fraction critical to accurate assessment of leaching from source zones. This study evaluated PFAS occurrence in lysimeter-collected porewater samples for two depth intervals at a decades-old aqueous film-forming foam (AFFF)-impacted field site quarterly for a year. Notably, site-wide Log10 (∑PFAS) concentrations did not significantly differ among sampling events despite highly variable sample yields due to a heterogeneous and dynamic soil moisture regime. However, Log10 (∑PFAS) concentrations were significantly higher in the shallow interval concordant with higher mean soil concentrations and higher total organic carbon (TOC) reflecting net retention, which is supported by soil-to-groundwater annual mass discharge estimates less than 0.2% of the total source mass for any given PFAS. Interestingly, PFAS-specific Log10 (soil-to-porewater ratios) significantly increased with soil concentration in both depth intervals contrary to concentration dependence resulting from the saturation of sorption sites potentially implicating self-assembly as an additional operative retention mechanism. Overall, these data validate the use of suction lysimeters for short-term site characterization deployments and emphasize the importance of in situ porewater samples for interrogating PFAS transport within source zones.

Eficacia y seguridad del equipo de aspiración de vacío extraoral para prevenir la infección por Sars-cov-2 en personal sanitario expuesto durante procedimientos estomatológicos / Efficacy and safety of extraoral vacuum aspiration equipment to prevent Sars-cov-2 infection in healthcare personnel exposed during stomatological procedures

ANTECEDENTES: El presente documento expone la evaluación de la eficacia y seguridad del equipo de aspiración de vacío extraoral en comparación con el eyector de saliva o el aspirador de secreción con flujo de succión no menor a 50 L/min (actualmente disponibles en la institución), para prevenir la infección por SARS-CoV-2 en personal sanitario expuesto durante procedimientos estomatológicos. ASPECTOS GENERALES: La pandemia por la enfermedad por coronavirus (COVID-19) ha tenido un impacto significativo en la atención odontológica (Abdelrahman et al. 2021; Cagetti et al. 2021). En diversos países, la atención odontológica ambulatoria fue interrumpida al inicio de la pandemia, a excepción de la atención de emergencia y urgencia dental (Abdelrahman et al. 2021; Cagetti et al. 2021). Esta interrupción de las atenciones odontológicas se debió a que 14,tc. 1 el cuidado dental implica un contacto cercano con el paciente durante periodos de tiempo "or prolongados, lo que genera preocupación sobre la transmisión del SARS-CoV-2 a través de la generación de aerosoles durante los procedimientos estomatológicos (Meng, Hua, and Bian 2020; Peng et al. 2020). De acuerdo con los Centers for Disease Control and Prevention (CDC), los dispositivos dentales que generan aerosoles y contaminan el aire incluyen al raspador ultrasónico, la pieza de mano dental de alta velocidad, jeringa de aire o agua, pulido y abrasión por aire (Centers for Disease Control and Prevention 2022). Estos procedimientos generan una mezcla de aerosoles y gotitas (miden 0.001 a 50 pm de diámetro) que contienen sangre y saliva con diversos patógenos (T. S. Singh and Mabe 2009), lo que genera un ambiente con alto potencial de transmisión de enfermedades como la COVID-19 (Peng et al. 2020). En base a este aumento del riesgo de transmisión de SARS-CoV-2 en los trabajadores de salud, los responsables de formular políticas y los equipos clínicos han optado por reevaluar y adaptar la atención odontológica en respuesta a los desafíos de la pandemia por COVID-19 (World Health Organization 2020b). METODOLOGÍA: La búsqueda sistemática se realizó en las bases de datos bibliográficas PubMed, The Cochrane Library, Web of Science y LILACS (Literatura Latinoamericana y del Caribe en Ciencias de la Salud). Asimismo, se realizó una búsqueda en las páginas web de grupos o instituciones que realizan revisiones sistemáticas (RS), evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC), tales como el National Institute for Health and Care Excellence (NICE), la Canadian Agency for Drugs and Technologies in Health (CADTH), el Scottish Medicines Consortium (SMC), la Haute Authorité de Santé (HAS), el Institute for Quality and Efficiency in HealthCare (IQWiG), el Institute for Clinical and Economic Review (ICER) yen la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), y en las principales instituciones o sociedades especializadas en odontología: la American Dental Association y la British Dental Association. Adicionalmente, se llevó a cabo una búsqueda manual en el motor de búsqueda Google utilizando los términos: (("extra-oral" OR extraoral) AND (vacuum OR aspirator OR suction) AND (COVID-19 OR SARS-CoV-2)) y (("extra-oral" OR extraoral) AND (vacuum OR aspirator OR suction) AND (virus OR viral)); revisando en las diez primeras páginas de resultados, a fin de poder identificar otras publicaciones de relevancia que pudiesen haber sido omitidas por la estrategia de búsqueda o que no hayan sido publicadas en las bases de datos bibliográficas consideradas. Finalmente, se realizó una búsqueda manual de las referencias de los estudios que ingresaron a la fase de texto completo, así como una búsqueda manual en la plataforma ClinicalTrials.gov para identificar ensayos clínicos aleatorizados (ECA) en curso o que no hayan sido publicados aún. RESULTADOS: GPC: gula de práctica clínica; ETS: evaluación de tecnologías sanitarias; RS: revisión sistemática; ECA: ensayo clínico aleatorizado; EO: estudio observacional; LILACS: Literatura Latinoamericana y del Caribe en Ciencias de la Salud; BRISA: Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas; JDA: Japan Dental Association, NHS: National Health Service. Flujograma adaptado de: Page MJ, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. CONCLUSIONES: El presente dictamen preliminar tuvo por objetivo realizar una evaluación sobre la eficacia y seguridad del equipo de aspiración de vacío extraoral en comparación con el eyector de saliva y el aspirador de secreción con flujo de succión no menor a 50 L/min (actualmente disponibles en la institución), para prevenir la infección por SARS-CoV-2 en personal sanitario expuesto durante procedimientos estomatológicos. Se identificaron una GPC (Hoshi et al.) y cinco documentos de recomendación realizados por Centers for Disease Control and Prevention, World Health Organization, Dental Council of India, Federal Ministry of Health of Nigeria y Government of Canada relevantes para el tema. La GPC emite una recomendación sobre la tecnología de interés; sin embargo, esta recomendación tuvo un muy bajo nivel de evidencia y recomendación débil debido a que se basó en un único estudio de simulación, lo cual no permite extrapolar los resultados a un entorno clínico de la vida real con pacientes o personal de salud. Ninguno de los documentos de recomendación incluidos emite recomendaciones sobre la intervención de interés (equipo de aspiración de vacío extraoral), sino que hacen referencia a los dispositivos evacuadores de alto volumen que son de uso intraoral, diferentes a lo solicitado. Asimismo, recomiendan otras medidas que se deben tomar en cuenta para mitigar la transmisión de enfermedades durante procedimientos generadores de aerosoles, donde destacan el uso de diques dentales, uso de equipo de protección personal adecuado, odontología a cuatro manos, y enjuagues bucales con clorhexidina. En el documento del MINSA, destacan una serie de disposiciones que deben instaurarse al momento de realizar una atención odontológica. Dentro de estas disposiciones destacan las medidas que debe utilizar el personal de salud dental antes, durante y después de la atención (principalmente, el uso del equipo de protección personal), en los establecimientos odontológicos (como una ventilación adecuada) y el esquema de vacunación completo del personal de salud. Las acciones combinadas tendrían un impacto positivo en la prevención de la infección por SARS-CoV-2. Por lo expuesto, el !ETS' no aprueba el uso del equipo de aspiración de vacío extraoral para prevenir la infección por SARS-CoV-2 en personal sanitario expuesto durante procedimientos estomatológicos.

Performance of a new single-use bronchoscope versus a marketed single-use comparator: a bench study.

BACKGROUND: Single-use flexible bronchoscopes eliminate cross contamination from reusable bronchoscopes and are cost-effective in a number of clinical settings. The present bench study aimed to compare the performance of a new single-use bronchoscope (Boston Scientific EXALT Model B) to a marketed single-use comparator (Ambu aScope 4), each in slim, regular and large diameters. METHODS: Three bronchoscopy tasks were performed: water suction and visualization, "mucus" mass (synthetic mucoid mixture) suctioned in 30 s, and "mucus" plug (thicker mucoid mixture) suction. Suction ability, task completion times, and subjective ratings of visualization and overall performance on a scale of one to 10 (best) were compared. All bronchoscopy tasks were completed by 15 physicians representing diversity in specialization including pulmonary, interventional pulmonary, critical care, anesthesia, and thoracic surgery. Each physician utilized the six bronchoscope versions with block randomization by bronchoscope and task. RESULTS: Aspirated mean mass of "mucus" using EXALT Model B Regular was comparable to that for an aScope 4 Large (41.8 ± 8.3 g vs. 41.5 ± 5.7 g respectively, p = 0.914). In comparisons of scopes with the same outer diameter, the aspirated mean mass by weight of water and "mucus" was significantly greater for EXALT Model B than for aScope 4 (p < 0.001 for all three diameters). Mean ratings for visualization attributes were significantly better for EXALT Model B compared to aScope 4 (p-value range 0.001-0.029). CONCLUSION: A new single-use bronchoscope provided strong suction capability and visualization compared to same-diameter marketed single-use comparators in a bench model simulation.

Methodological assessment of the reduction of dissemination risk and quantification of debris dispersion during dissection with a surgical aspirator.

OBJECTIVE: We developed an actuator-driven pulsed water jet (ADPJ) device to achieve maximal lesion dissection with minimal risk of normal structural damage. Despite the unique dissection characteristics, there is a risk of dissemination of tissue dispersion; however, there is no established method to quantify the dispersion. Hence, this study aimed to assess the factors associated with dispersion and propose a simple experimental method using spectrophotometry to evaluate the degree of dispersion in a wet field. RESULTS: Methylene blue-stained brain phantom gelatin was immersed in a chamber with distilled water solution and dissected with an ADPJ. The dispersed gelatin solution was stirred and warmed to dissolve. The absorbance of the solution was measured spectrophotometrically. First, a reference standard curve was constructed to confirm the relationship between the absorbance and the amount of the dispersed gelatin. A clear proportional correlation was observed, which indicated that absorbance measurements can help evaluate the amount of dispersion. Using this method, we revealed that a high dissection force, insufficient suction, and inappropriate long distance between the nozzle tip and the target were associated with increased dispersion. This method might constitute a versatile and reliable approach to evaluate dispersion and aid in the development of surgical devices.

Assessment of wound healing efficacy and tolerability using CicatrylTM cream based on a suction blister model in healthy subjects

Background: CicatrylTM cream, a topical medical device, is indicated for the treatment of superficial wounds and small skin injuries. Objectives: To assess the efficacy and tolerability of CicatrylTM cream by measuring the recovery of the skin barrier after inducing wounds. Materials & Methods: A suction blister of about 6-mm diameter was induced on the inner side of each forearm of 44 healthy subjects. Using a process of randomisation, CicatrylTM cream was then applied to one wound for a maximum duration of 14 days, while the other wound was left untreated. The primary objective was to evaluate the effect of the test product on wound healing at Day 6, by comparing treated versus untreated wound areas measured by macrophotography. Secondary objectives were to evaluate healing, cutaneous barrier restoration and subjective efficacy of the cream as well as tolerability. Results: The mean wound area (± SD) at Day 6 was significantly smaller for treated wounds compared with untreated wounds (1.76±4.71 vs 15.76±7.61 mm2; p < 0.0001). For treated wounds, wound healing between Days 1 and 6 was 1.6-fold faster compared with untreated wounds (-7.90 vs-4.79 mm2/day; p < 0.0001), and the wounds healed in approximately half the time (6.8 vs 12.2 days for untreated wounds). Cutaneous barrier restoration occurred earlier for treated wounds (Day 6 vs Day 8 for untreated wounds). The cream was well tolerated, and no serious adverse events were observed. Conclusion: CicatrylTM cream improves wound healing, especially within the first six days, if applied in accordance with the manufacturer's instructions.

Assessment of posterior tongue mobility using lingual-palatal suction: Progress towards a functional definition of ankyloglossia.

BACKGROUND: A functional definition of ankyloglossia has been based on assessment of tongue mobility using the tongue range of motion ratio (TRMR) with the tongue tip extended towards the incisive papilla (TIP). Whereas this measurement has been helpful in assessing for variations in the mobility of the anterior one-third of the tongue (tongue tip and apex), it may be insufficient to adequately assess the mobility of the posterior two-thirds body of the tongue. A commonly used modification is to assess TRMR while the tongue is held in suction against the roof of the mouth in lingual-palatal suction (LPS). OBJECTIVE: This study aims to explore the utility and normative values of TRMR-LPS as an adjunct to functional assessment of tongue mobility using TRMR-TIP. STUDY DESIGN: Cross-sectional cohort study of 611 subjects (ages: 3-83 years) from the general population. METHODS: Measurements of tongue mobility using TRMR were performed with TIP and LPS functional movements. Objective TRMR measurements were compared with subjective self-assessment of resting tongue position, ease or difficulty elevating the tongue tip to the palate, and ease or difficulty elevating the tongue body to the palate. RESULTS: There was a statistically significant association between the objective measures of TRMR-TIP and TRMR-LPS and subjective reports of tongue mobility. LPS measurements were much more highly correlated with differences in elevating the posterior body of the tongue as compared to TIP measurements (R2 0.31 vs 0.05, P < .0001). CONCLUSIONS: This study validates the TRMR-LPS as a useful functional metric for assessment of posterior tongue mobility.

Effectiveness of suction valve button removal in retrieving resected colon polyps for better histological assessment: Propensity score matching analysis.

BACKGROUND AND AIM: Fragmentation of endoscopically resected colorectal polyps during retrieval is one of the limitations for appropriate pathological diagnosis; however, little is known about steps to reduce it. We aimed to evaluate the effect of removing the suction valve button, which is one of the intricate parts of the endoscope, during polyp suction retrieval for fragmentation and pathological diagnosis. METHODS: We retrospectively reviewed the polyps retrieved by suctioning. We used the propensity score matching method to adjust for difference between the button-attached and button-removed groups. Outcomes of fragmentation, pathological diagnosis of non-neoplastic polypectomy (NNP), and pathological cut-end among neoplastic lesions were evaluated. RESULTS: On the basis of propensity score matching, 322 pairs of cases were selected for analysis. After matching, the difference in the variables between the two groups was closely balanced. The fragmentation rate was significantly different between the groups (button-attached 36.6% vs. button-removed 22.4%, P < 0.001). No significant difference in the NNP rate was observed between the two groups (button-attached 8.4% vs. button-removed 9.9%). The rate of unclear cut-end was lower in the button-removed group than in the button-attached group (16.2% vs. 9.1%, P = 0.010). In the multivariate analysis, button removal was independently associated with reductions of fragmentation (odds ratio [OR] 0.508, P < 0.001) and unclear cut-end (OR 0.503, P = 0.009). Also, NNP was associated with smaller lesion size (OR 0.364, P < 0.001), but not with button removal. CONCLUSIONS: Suction valve button removal during polyp suction retrieval was an effective method to decrease the rates of fragmentation and histological unclear margins.

Expertise, experience, and excellence. Twenty years of patient involvement in health technology assessment at NICE: an evolving story.

From its inception in 1999, the National Institute for Health and Care Excellence (NICE) committed to including the expertise, experiences, and perspectives of lay people, patients and carers, and patient organizations in its health technology assessments (HTAs). This is our story of patient involvement in HTA: from early methods designed for use when assessing medicines, widening to address the different requirements of HTAs for interventional procedures, medical technologies, and diagnostic technologies. We also chart the evolution and development of all our patient involvement methods over the past 20 years through regular evaluation and by responding to external challenge. However, we know that processes and methods alone are not enough. Through case studies we demonstrate the value of patient involvement in HTA and highlight the unique perspectives and experiences that patients bring to HTA committees. Finally, we discuss the underpinning principles and commitments that have made NICE a world leader in delivering meaningful and legitimate patient involvement.

Interventions to reduce contaminated aerosols produced during dental procedures for preventing infectious diseases.

BACKGROUND: Many dental procedures produce aerosols (droplets, droplet nuclei and splatter) that harbour various pathogenic micro-organisms and may pose a risk for the spread of infections between dentist and patient. The COVID-19 pandemic has led to greater concern about this risk. OBJECTIVES: To assess the effectiveness of methods used during dental treatment procedures to minimize aerosol production and reduce or neutralize contamination in aerosols. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases on 17 September 2020: Cochrane Oral Health's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (in the Cochrane Library, 2020, Issue 8), MEDLINE Ovid (from 1946); Embase Ovid (from 1980); the WHO COVID-19 Global literature on coronavirus disease; the US National Institutes of Health Trials Registry (ClinicalTrials.gov); and the Cochrane COVID-19 Study Register. We placed no restrictions on the language or date of publication. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on aerosol-generating procedures (AGPs) performed by dental healthcare providers that evaluated methods to reduce contaminated aerosols in dental clinics (excluding preprocedural mouthrinses). The primary outcomes were incidence of infection in dental staff or patients, and reduction in volume and level of contaminated aerosols in the operative environment. The secondary outcomes were cost, accessibility and feasibility. DATA COLLECTION AND ANALYSIS: Two review authors screened search results, extracted data from the included studies, assessed the risk of bias in the studies, and judged the certainty of the available evidence. We used mean differences (MDs) and 95% confidence intervals (CIs) as the effect estimate for continuous outcomes, and random-effects meta-analysis to combine data. We assessed heterogeneity. MAIN RESULTS: We included 16 studies with 425 participants aged 5 to 69 years. Eight studies had high risk of bias; eight had unclear risk of bias. No studies measured infection. All studies measured bacterial contamination using the surrogate outcome of colony-forming units (CFU). Two studies measured contamination per volume of air sampled at different distances from the patient's mouth, and 14 studies sampled particles on agar plates at specific distances from the patient's mouth. The results presented below should be interpreted with caution as the evidence is very low certainty due to heterogeneity, risk of bias, small sample sizes and wide confidence intervals. Moreover, we do not know the 'minimal clinically important difference' in CFU. High-volume evacuator Use of a high-volume evacuator (HVE) may reduce bacterial contamination in aerosols less than one foot (~ 30 cm) from a patient's mouth (MD -47.41, 95% CI -92.76 to -2.06; 3 RCTs, 122 participants (two studies had split-mouth design); very high heterogeneity I² = 95%), but not at longer distances (MD -1.00, -2.56 to 0.56; 1 RCT, 80 participants). One split-mouth RCT (six participants) found that HVE may not be more effective than conventional dental suction (saliva ejector or low-volume evacuator) at 40 cm (MD CFU -2.30, 95% CI -5.32 to 0.72) or 150 cm (MD -2.20, 95% CI -14.01 to 9.61). Dental isolation combination system One RCT (50 participants) found that there may be no difference in CFU between a combination system (Isolite) and a saliva ejector (low-volume evacuator) during AGPs (MD -0.31, 95% CI -0.82 to 0.20) or after AGPs (MD -0.35, -0.99 to 0.29). However, an 'n of 1' design study showed that the combination system may reduce CFU compared with rubber dam plus HVE (MD -125.20, 95% CI -174.02 to -76.38) or HVE (MD -109.30, 95% CI -153.01 to -65.59). Rubber dam One split-mouth RCT (10 participants) receiving dental treatment, found that there may be a reduction in CFU with rubber dam at one-metre (MD -16.20, 95% CI -19.36 to -13.04) and two-metre distance (MD -11.70, 95% CI -15.82 to -7.58). One RCT of 47 dental students found use of rubber dam may make no difference in CFU at the forehead (MD 0.98, 95% CI -0.73 to 2.70) and occipital region of the operator (MD 0.77, 95% CI -0.46 to 2.00). One split-mouth RCT (21 participants) found that rubber dam plus HVE may reduce CFU more than cotton roll plus HVE on the patient's chest (MD -251.00, 95% CI -267.95 to -234.05) and dental unit light (MD -12.70, 95% CI -12.85 to -12.55). Air cleaning systems One split-mouth CCT (two participants) used a local stand-alone air cleaning system (ACS), which may reduce aerosol contamination during cavity preparation (MD -66.70 CFU, 95% CI -120.15 to -13.25 per cubic metre) or ultrasonic scaling (MD -32.40, 95% CI - 51.55 to -13.25). Another CCT (50 participants) found that laminar flow in the dental clinic combined with a HEPA filter may reduce contamination approximately 76 cm from the floor (MD -483.56 CFU, 95% CI -550.02 to -417.10 per cubic feet per minute per patient) and 20 cm to 30 cm from the patient's mouth (MD -319.14 CFU, 95% CI - 385.60 to -252.68). Disinfectants ‒ antimicrobial coolants Two RCTs evaluated use of antimicrobial coolants during ultrasonic scaling. Compared with distilled water, coolant containing chlorhexidine (CHX), cinnamon extract coolant or povidone iodine may reduce CFU: CHX (MD -124.00, 95% CI -135.78 to -112.22; 20 participants), povidone iodine (MD -656.45, 95% CI -672.74 to -640.16; 40 participants), cinnamon (MD -644.55, 95% CI -668.70 to -620.40; 40 participants). CHX coolant may reduce CFU more than povidone iodine (MD -59.30, 95% CI -64.16 to -54.44; 20 participants), but not more than cinnamon extract (MD -11.90, 95% CI -35.88 to 12.08; 40 participants). AUTHORS' CONCLUSIONS: We found no studies that evaluated disease transmission via aerosols in a dental setting; and no evidence about viral contamination in aerosols. All of the included studies measured bacterial contamination using colony-forming units. There appeared to be some benefit from the interventions evaluated but the available evidence is very low certainty so we are unable to draw reliable conclusions. We did not find any studies on methods such as ventilation, ionization, ozonisation, UV light and fogging. Studies are needed that measure contamination in aerosols, size distribution of aerosols and infection transmission risk for respiratory diseases such as COVID-19 in dental patients and staff.

Intubation Setting, Aspiration, and Ventilator-Associated Conditions.

BACKGROUND: Patients experience endotracheal intubation in various settings with wide-ranging risks for postintubation complications such as aspiration and ventilator-associated conditions. OBJECTIVES: To evaluate associations between intubation setting, presence of aspiration biomarkers, and clinical outcomes. METHODS: This study is a subanalysis of data from the NO-ASPIRATE single-blinded randomized clinical trial. Data were prospectively collected for 513 adult patients intubated within 24 hours of enrollment. Patients with documented aspiration events at intubation were excluded. In the NO-ASPIRATE trial, intervention patients received enhanced oropharyngeal suctioning every 4 hours and control patients received sham suctioning. Tracheal specimens for α-amylase and pepsin tests were collected upon enrollment. Primary outcomes were ventilator hours, lengths of stay, and rates of ventilator-associated conditions. RESULTS: Of the baseline tracheal specimens, 76.4% were positive for α-amylase and 33.1% were positive for pepsin. Proportions of positive tracheal α-amylase and pepsin tests did not differ significantly between intubation locations (study hospital, transfer from other hospital, or field intubation). No differences were found for ventilator hours or lengths of stay. Patients intubated at another hospital and transferred had significantly higher ventilator-associated condition rates than did those intubated at the study hospital (P = .02). Ventilator-associated condition rates did not differ significantly between patients intubated in the field and patients in other groups. CONCLUSIONS: Higher ventilator-associated condition rates associated with interhospital transfer may be related to movement from bed, vehicle loading and unloading, and transport vehicle vibrations. Airway assessment and care may also be suboptimal in the transport environment.

Biological Glue as an Alternative to Suction Drainage in Tissue-Expanded Flaps in Children: Cost-Effectiveness Study.

INTRODUCTION: Biological glue is already used as a hemostatic agent and tissue adhesive in plastic surgery. This study evaluates the use of this glue as an alternative to suction drainage for the adhesion of tissue-expanded flaps in pediatric patients. METHODS: This is a retrospective, multicenter case-control study on 48 flap procedures conducted on 42 children (5 months-12 years of age) between 2004 and 2017, comparing a "glue" group (n = 24) with a control group (n = 24), in which a classic redon drain was used. The control patients were matched according to age, etiology, location of the lesion, and the size of the expander. The primary end point was the duration of hospital stay. RESULTS: The conditions were 24 cases of congenital nevus, 14 of cicatricial alopecia, and 10 of sebaceous hamartoma. Twenty-nine lesions were located on the scalp, 15 on the back, 2 on the thigh, and 2 on the buttocks.The average surgical durations (48 ± 24 vs 63 ± 32 minutes, P = 0.13) and average room occupancy time (126 ± 21 vs 139 ± 44 minutes, P = 0.29) were similar between the glue group and the control group. However, the average duration of hospital stay was lower in the glue group (1.5 ± 1.5 days) than in the control group (3.6 ± 1.3 days, P < 0.0001). The complication rates between the groups were similar. CONCLUSIONS: The application of glue on expanded flaps is as reliable as suction drainage with the advantage of reducing the duration of hospital stay and potentially enabling outpatient treatment for certain patients.

Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation.

BACKGROUND: The purpose of this study was to compare the reliability and reproducibility of the traditional qualitative method of assessing uterine cervical stiffness with those of a quantitative method using a novel device based on the aspiration technique. METHODS: Five silicone models of the uterine cervix were created and used to simulate different cervical stiffnesses throughout gestation. The stiffness of the five cervix models was assessed both by digital palpation (firm, medium and soft) and with the Pregnolia System. Five self-trained participants conducted the device-based assessment, whereas 63 obstetricians and midwives, trained in digital palpation, conducted the cervical palpation. RESULTS: The results of the two methods were analyzed in terms of inter-and intra-observer variability. For digital palpation, there was no common agreement on the assessment of the stiffness, except for the softest cervix. When assessing the same cervix model for a second time, 76% of the obstetricians and midwives disagreed with their previous assessment. In contrast, the maximum standard deviation for the device-based stiffness assessment for intra- and inter-observer variability was 3% and 3.4%, respectively. CONCLUSIONS: This study has shown that a device based on the aspiration technique provides obstetricians and midwives with a method for objectively and repeatably assess uterine cervical stiffness, which can eliminate the need to rely solely on a subjective interpretation, as is the case with digital palpation.