Body Fit With a Pouching System With Concave Contour for People With an Outward Peristomal Body Profile: Effects on Leakage, Wear Time, and Quality of Life: A Randomized Controlled Cross-Over Trial.

PURPOSE: The purpose of the study was to investigate the fit of a two-piece pouching system with a concave-shaped skin barrier on people with an outward peristomal body profile and its effect on leakage, wear time, and quality of life (QoL) related to using an ostomy product. DESIGN: Randomized, controlled, open-label, cross-over trial. SUBJECTS AND SETTINGS: The sample comprised 53 subjects with outward peristomal body profiles and problems with leakage of ostomy effluent from their pouching system. Participants were randomized to the concave two-piece pouching system or a comparator (two-piece pouching system with a flat skin barrier) for 3 weeks. Subjects were then crossed over to the opposite skin barrier for an additional 3 weeks. The study was conducted in Denmark, Norway, Germany, and the Netherlands; data were collected in multiple ambulatory clinics or during home visits. METHODS: The primary end point was the ability of the skin barrier to fit body contours; secondary outcomes were leakage of effluent from the pouching system, wear time, and QoL related to using an ostomy product via the validated Ostomy-Q questionnaire. Primary comparisons between concave and comparator pouching systems were evaluated using proportional odds models and mixed models taking test period into account. RESULTS: Analysis included randomized subjects who had been exposed to at least one product and with information on at least one end point (full-analysis-set, n = 52). The concave pouching system provided a better fit to body contours than the comparator (P< .001) and reduced the degree of leakage underneath the skin barrier (LS mean difference = -1.84, 95% CI -3.31 to -0.37; P = .016). Participants experienced fewer episodes of leakage outside the skin barrier when using concave versus comparator pouching system (13.0% vs. 26.7%, respectively). Participants reported significant improvements in QoL (LS mean difference = 14.3; 95% CI 9.4 to 19.2; P < .001). No significant difference in wear time between skin barrier shapes was reported. CONCLUSIONS: Study findings indicate that a pouching system with a concave skin barrier achieved a better body fit on people with an outward peristomal body profile and resulted in fewer leakage incidents and higher QoL compared to using a pouching system with a flat skin barrier.

Algoritmo de Indicação de Equipamento Coletor para Estomias / Algorithm for Indication of Collector Equipment for Stomas / Algoritmo para la Indicación de Equipos Colectores para Estomas

Objetivo:Relatar a experiência de uma equipe de enfermeiros estomaterapeutas na construção de um algoritmo para a indicação de equipamento coletor para estomias de eliminação. Método: Relato de experiência, do período de janeiro de 2018 a setembro de 2019, sobre o processo de construção de um algoritmo para indicação de equipamento coletor para estomias de eliminação. Resultados: A partir de determinadas características clínicas (parâmetros de avaliação) e da categorização dos equipamentos coletores (solução), foi desenvolvido um algoritmo para indicação de equipamento coletor para estomias de eliminação. Conclusão: Espera-se que esse instrumento possa auxiliar os enfermeiros na sua prática profissional quanto à escolha do equipamento coletor e na construção de protocolos clínicos.

Objective:To report the experience of a team of enterostomal therapists in the construction of an algorithm for the indication of collecting equipment for elimination stomas. Method: Experience report, from January 2018 to September 2019, on the process of building an algorithm to indicate collecting equipment for elimination stomas. Results: Based on certain clinical characteristics (assessment parameters) and the categorization of collecting equipment (solution), an algorithm was developed to indicate collecting equipment for elimination stomas. Conclusion: It is expected that this instrument can help nurses in their professional practice regarding the choice of collecting equipment and the construction of clinical protocols.

Objetivo:Relatar la experiencia de un equipo de enfermeros estomaterapeutas en la construcción de un algoritmo para la indicación de equipos recolectores para estomas de eliminación. Método: Informe de experiencia, de enero de 2018 a septiembre de 2019, sobre el proceso de construcción de un algoritmo para indicar equipos colectores para estomas de eliminación. Resultado: A partir de ciertas características clínicas (parámetros de evaluación) y la categorización de los equipos colectores (solución), se desarrolló un algoritmo para indicar equipos colectores para estomas de eliminación. Conclusión: Se espera que este instrumento pueda ayudar a los enfermeros en su práctica profesional en cuanto a la elección de equipos de recolección y la construcción de protocolos clínicos.

3D-Printed Ostomy Flange Stabilizer.

BACKGROUND: One of the coauthors with tetraplegia (quadriplegia) and a colostomy invented an ostomy flange stabilizer to act as a temporary backplate and aid in pouch changes. DEVICE DEVELOPMENT: In an interactive design process, a 3D-printed ostomy flange stabilizer device was created. The resulting device can be adapted to 3 standard stoma appliance sizes. The stabilizer is reversible, allowing right- and left-handed people to use it on right- or left-sided stomas. Anyone with a 3D printer can print this device from an open-access Web site. CONCLUSION: This device may be of use to many with ostomies and especially those with impaired dexterity.A 3D-printed ostomy flange stabilizer is described. 3D printing allows patient inventions to be disseminated without commercialization.

Evaluación comparativa, mediante ensayos biomecánicos, de dispositivos de ostomía de dos piezas / Comparative evaluation through biomechanical tests of two-piece ostomy systems

OBJETIVO: comparar las propiedades mecánicas de los dispositivos de ostomía de dos piezas más empleados en España (Coloplast -o Fabricante I- y Fabricante II), mediante la realización de ensayos mecánicos. MÉTODO: los ensayos se realizaron en el Instituto de Biomecánica de Valencia (IBV), empleándose una máquina universal de ensayos MTS INSIGHT/468, con unas condiciones ambientales controladas de temperatura (22-24 ºC) y de humedad (39-41%). El tamaño de la muestra para cada uno de los ensayos fue de 10 unidades para cada tipo de sistema. Se llevaron a cabo tres pruebas: 1) Ensayo de resistencia a la degradación del adhesivo en solución salina; 2) Ensayo de resistencia al estallido del canal de vaciado de las bolsas abiertas; 3) Ensayo de resistencia a la separación entre el disco y la bolsa. RESULTADOS: en el ensayo de resistencia a la degradación del adhesivo en solución salina, los dos adhesivos, sometidos a periodos de degradación de 6 y 12 horas en solución salina a 37 ºC, presentaron diferencias significativas a favor del Fabricante I (Coloplast) para los dos periodos. En el ensayo de resistencia al estallido del canal de vaciado de las bolsas abiertas, con las bolsas llenas de agua, cerradas y pegadas sobre una plancha lisa, después de aplicar cargas de compresión hasta el estallido del canal, los dos sistemas no mostraron diferencias significativas. En el ensayo de resistencia a la separación entre el disco y la bolsa, ensamblada cada bolsa a su disco correspondiente y aplicadas cargas de tracción hasta la separación, también hubo diferencias significativas a favor del Fabricante I (Coloplast). CONCLUSIÓN: se puede afirmar que ambos sistemas son seguros, pero el sistema Coloplast presenta mayor durabilidad ante la degradación por el efluente y mayor coeficiente de seguridad frente a la separación entre la bolsa y el disco

OBJECTIVE: to compare the mechanical characteristics of the two-piece ostomy systems most widely used in Spain: (Coloplast or Manufacturer I and Manufacturer II), through mechanical tests. METHOD: tests were conducted in the Instituto de Biomecánica de Valencia (IBV), using a MTS INSIGHT/468 universal test machine, under environmental conditions of controlled temperature (22-24 ºC) and humidity (39-41%). The sample size for each test was 10 units per each type of system. Three tests were conducted: 1) Resistance test to degradation of the adhesive in saline solution; 2) Resistance test to burst of the outlet in open pouches; 3) Resistance test for the separation between the disc and the pouch. RESULTS: in the test of resistance to degradation of the adhesive in saline solution, both adhesives were submitted to 6 and 12-hour degradation periods in saline solution at 37 ºC, and significant differences were presented in favour of Manufacturer 1 (Coloplast) for both time periods. In the resistance test for the burst of the outlet in open pouches, the pouches were filled with water, closed and stuck on a flat plate; after applying compression charges until the outlet burst, both systems did not show any significant differences. In the resistance test for the separation between disc and pouch, each pouch was assembled with its disc, and traction charges were applied until their separation; there were significant differences in favour of Manufacturer I (Coloplast). CONCLUSION: it can be stated that both systems are safe, but the Coloplast system shows higher durability in terms of degradation by effluent, and a higher safety coefficient regarding the separation between pouch and disc

Cancer survivors' challenges with ostomy appliances and self-management: a qualitative analysis.

PURPOSE: An ostomy poses significant health-related quality of life (HRQOL) issues for cancer survivors. Survivors must learn to manage pouching appliances and adjust to the psychosocial consequences of living with an ostomy. We explored, through qualitative analysis, the challenges with self-management and ostomy appliances reported by cancer survivors. METHODS: Pooled data from two studies with a question on the greatest challenge of living with an ostomy and intervention session notes were analyzed using content analysis approach. The themes were reviewed and agreed upon by the research team, and counts were tallied for each theme based on the number of times they were mentioned by participants. RESULTS: Of the 928 greatest challenge responses and session notes, a total of 106 mentions (11%) were focused on ostomy appliances, associated repercussions, and time taken for ostomy care. Eight themes emerged: bleeding, pain, leakage, skin problems/irritation/rash, wafer-related issues, materials getting under the wafer, time to care for ostomy, and solutions to clean the stoma. Challenges described included poor wafer adherence, allergic reactions to adhesives, and pain around the stoma site. These challenges resulted in anxiety related to leakage, odor, and/or skin irritation, which negatively impacted on participation in social activities and self-confidence with ostomy care. CONCLUSIONS: Cancer survivors living with an ostomy experience multiple obstacles with ostomy appliances and caring for their ostomy. Continued innovation in ostomy appliance design and technology is needed to help cancer survivors with successfully managing ostomy care.

Gestión de las ostomías en un centro sociosanitario / Handling of ostomies in a socio-health center

En octubre de 2016 se creaba en nuestro centro sociosanitario (CSS) la figura de la enfermera gestora en ostomías (EGO). Esta se implementa como consecuencia del creciente número de personas que anualmente se ostomizan en los servicios de cirugía y urología de nuestro hospital de agudos de referencia, y que de manera indirecta repercute en nuestro día a día asistencial. A lo largo del año 2017 se valoraron y censaron todos los pacientes ingresados en nuestro CSS con algún tipo de derivación intestinal, urológica, estoma de nutrición o de drenaje. A partir de su valoración se establecía un plan de curas ante las posibles complicaciones detectadas, así como un plan de educación sanitaria para aquellos pacientes dependientes en cuanto al manejo global de su ostomía, principalmente en los recientemente ostomizados. Ingresaron 68 pacientes, que presentaban un total de 84 ostomías de diferente etiología. Un total de 38 (55,88%) de estos pacientes presentaron algún tipo de complicación detectada en la valoración inicial o bien aparecida durante su estancia en nuestro centro. Gracias a este seguimiento se consigue minimizar el tiempo transcurrido desde la detección hasta el abordaje de las posibles complicaciones, reducir el número de traslados de pacientes a servicios de urgencias o consulta de la estomaterapeuta de zona. Así mismo, se consigue disminuir los días de ingreso por complicaciones en ostomías, aprovechar mejor los recursos materiales y optimizar el tiempo del personal sanitario, facilitando a su vez la reintegración precoz del paciente a su vida habitual

In October of the year 2016, the figure of the nurse in ostomies was created in our sociosanitary center. This is implemented as a consequence of the growing number of people that are annually ostomized in the surgery and urology services of our reference acute hospital, and that indirectly affects our day-to-day care. Throughout the year 2017 all the patients admitted to our CSS were evaluated with some type of intestinal, urological, nutrition or drainage stoma, enumerating them all. Based on its assessment, a cure plan was established for the possible complications detected, as well as a health education plan for those patients who are dependent on the overall management of their ostomy, mainly in the recently ostomized. 68 patients were admitted, presenting a total of 84 ostomies of different etiology. 38 of these (55.88%) presented some type of complication detected in the initial assessment or appeared during their stay in our center. Thanks to this monitoring, it is possible to minimize the time elapsed from detection to the approach of possible complications, reduce the number of patient transfers to emergency services or consultation of the area stomatherapist. Likewise, it is possible to reduce the number of admission days due to ostomy complications, make better use of material resources and optimize the time of health personnel, while facilitating the early reintegration of the patient into his / her habitual life

Calidad percibida por ostomizados en la utilización de un nuevo producto que contiene miel de manuka / Quality perceived by ostomized on the use of a new product containing manuka hone

La calidad es un concepto fundamental en el avance de todo producto sanitario. Objetivo. Evaluar el grado de calidad percibida por los usuarios en una bolsa colectora con miel de Manuka integrada en el protector cutáneo para ostomías. Metodología. Estudio descriptivo transversal comparativo realizado entre diciembre de 2017 y marzo de 2018, en distintos centros españoles. Criterios de selección: ser portador de una ostomía intestinal temporal o permanente, ≥18 años y no haber utilizado el nuevo producto. Se empleó un cuestionario autodiseñado con 16 ítems. Las variables analizadas fueron: tipo de estoma del paciente, cambio de frecuencia de bolsa, manejo del nuevo dispositivo, estado de la piel periestomal, nivel de satisfacción del usuario y necesidad del uso de accesorios complementarios. Resultados. Se incluyeron 31 pacientes. El 58% era portador de una ileostomía. El 71% consideró que la nueva bolsa era mejor o mucho mejor con un filtro más efectivo y una muy buena calidad del apósito (61,3%). Un 25,6% indicó haber reducido el número de cambios precisado. El 87,10% indicó que la bolsa era más fácil de colocar y al 64,5% le resultó más fácil despegarla con menor presencia de residuos (67,7%). Un 25,8% señaló requerir un número menor de accesorios. Conclusiones. La reducción en el número de cambios de bolsas y el mayor nivel de confort se relaciona con la rápida adherencia a la piel y la ventana de inspección. El mayor nivel de satisfacción se relaciona con la buena calidad del apósito y del filtro, la mejor adaptación a la piel y el cuidado de esta

Objective. To evaluate the level of quality perceived by users on a collection bag with Manuka honey integrated into the ostomy skin protector. Methodology. Descriptive transversal study realised between December 2017 and March 2018, in different Spanish centers. Selection criteria: To be a carrier of a temporary or permanent intestinal ostomy, ≥ 18 years old and not to have used the new product. The patients answered a self-designed questionnaire with 16 items. The variables analyzed were: Type of patient stoma, change of bag frequency, use of the new product, peristomal skin condition, level of user satisfaction and need for the use of complementary accessories. Results. 31 patients were included. 58% were carriers of an ileostomy. The 71% considered that the new bag was better or much better with a more effective filter and a very good quality of the dressing (61.3%). A 25.6% indicated that they had reduced the number of changes of the bag. The 87.10% indicated that the bag was easier to place and 64.5% said that it was easier to take off with less presence of waste (67.7%). A 25.8% pointed that the new bag required less accessories. Conclusions. The reduction in the number of bag changes and the higher level of comfort is related to the quick adherence to the skin and the inspection window. The highest level of satisfaction is related to the good quality of the dressing and the filter, the best adaptation to the skin and the care of it

Fistula Isolation and the Use of Negative Pressure to Promote Wound Healing: A Case Study.

BACKGROUND: A 54-year-old morbidly obese woman with a small bowel obstruction and large ventral hernia was admitted to hospital. She underwent an exploratory laparotomy, lysis of adhesions, and ventral hernia repair with mesh placement. She subsequently developed an enteroatmospheric fistula; several months of hospital care was required to effectively manage the wound and contain effluent from the fistula. METHODS: Several approaches were used to manage output from the fistula during her hospital course. She was initially discharged to a skilled nursing facility where a fistula management pouch was used for several months to encompass the wound and contain effluent, but this method ultimately proved ineffective. The fistula was then isolated using a collapsible enteroatmospheric fistula isolation device and an ostomy appliance to contain effluent. CONCLUSION: The application of the collapsible enteroatmospheric fistula isolation and effluent containment devices in conjunction with negative-pressure wound therapy produced positive patient outcomes; it improved patient satisfaction with fistula management, promoted wound healing, and diminished cost.

Differences in Ostomy Pouch Seal Leakage Occurrences Between North American and European Residents.

PURPOSE: The purpose of this study was to compare experiences and concerns about pouch seal leakage between persons with ostomies residing in North America (Canada and the United States) and Europe (United Kingdom, Netherlands, Sweden, Germany, Belgium, France, and Italy). Differences in reported pouch wear time and accessories used between the 2 groups were also examined. DESIGN: Secondary analysis of data from a cross-sectional study (Ostomy Life Study). SUBJECTS AND SETTINGS: Responses from persons residing in European countries (n = 1939) were compared with responses of 1387 individuals residing in North American countries. METHODS: Persons with an ostomy completed a questionnaire that focused on 4 topics related to the daily use of an ostomy pouching system (pouch seal leakage, ballooning, appearance of pouching system such as color and size of the pouch and whether it is discrete under clothing, and coupling failure of 2-piece pouching systems). Pouch seal leakage was defined as stomal effluent seeping between the skin and the wafer of the ostomy pouching system. Statistical analysis was performed using a proportional odds model including various variable effects. Special attention was given to frequency of pouch seal leakage occurrences. All tests were 2-sided; P values ≤.05 were deemed statistically significant. RESULTS: Participants living in the North American countries indicated they were more likely to experience leakage from the ostomy (odds ratio = 2.610, 95% CI 2.187-3.115; P < .0001). Findings also indicated they were more likely to worry about pouch seal leakage than those in the European countries' data set (odds ratio = 2.722, 95% CI 2.283-3.246; P < .0001). Participants residing in the North American countries had significantly longer wear times than those participants in the European countries (P < .0001, χ test). The use of accessories was associated with a longer pouching system wear time. CONCLUSION: Study results suggest that participants from the North American countries indicated significantly more experience with and worries about leakage and longer wear time than the participants from the European population. Additional research is needed to determine the reasons for these differences.

Meta-analysis of prophylactic mesh to prevent parastomal hernia.

BACKGROUND: Rates of parastomal hernia following stoma formation remain high. Previous systematic reviews suggested that prophylactic mesh reduces the rate of parastomal hernia; however, a larger trial has recently called this into question. The aim was to determine whether mesh placed at the time of primary stoma creation prevents parastomal hernia. METHODS: The Cochrane Central Register of Controlled Trials, MEDLINE, Embase and CINAHL were searched using medical subject headings for parastomal hernia, mesh and prevention. Reference lists of identified studies, clinicaltrials.gov and the WHO International Clinical Trials Registry were also searched. All randomized clinical trials were included. Two authors extracted data from each study independently using a purpose-designed sheet. Risk of bias was assessed by a tool based on that developed by Cochrane. RESULTS: Ten randomized trials were identified among 150 studies screened. In total 649 patients were included in the analysis (324 received mesh). Overall the rates of parastomal hernia were 53 of 324 (16·4 per cent) in the mesh group and 119 of 325 (36·6 per cent) in the non-mesh group (odds ratio 0·24, 95 per cent c.i. 0·12 to 0·50; P < 0·001). Mesh reduced the rate of parastomal hernia repair by 65 (95 per cent c.i. 28 to 85) per cent (P = 0·02). There were no differences in rates of parastomal infection, stomal stenosis or necrosis. Mesh type and position, and study quality did not have an independent effect on this relationship. CONCLUSION: Mesh placed prophylactically at the time of stoma creation reduced the rate of parastomal hernia, without an increase in mesh-related complications.

Use of Convexity in Ostomy Care: Results of an International Consensus Meeting.

Ostomy skin barriers that incorporate a convexity feature have been available in the marketplace for decades, but limited resources are available to guide clinicians in selection and use of convex products. Given the widespread use of convexity, and the need to provide practical guidelines for appropriate use of pouching systems with convex features, an international consensus panel was convened to provide consensus-based guidance for this aspect of ostomy practice. Panelists were provided with a summary of relevant literature in advance of the meeting; these articles were used to generate and reach consensus on 26 statements during a 1-day meeting. Consensus was achieved when 80% of panelists agreed on a statement using an anonymous electronic response system. The 26 statements provide guidance for convex product characteristics, patient assessment, convexity use, and outcomes.

Convex stoma appliances: an audit of stoma care nurses.

This article observes the complexities surrounding the use of convex appliances within the specialist sphere of stoma care. It highlights some of the results taken from a small audit carried out with 24 stoma care nurses examining the general use of convex appliances and how usage of convex products has evolved, along with specialist stoma care practice.

Comparing ostomates' perceptions of hydrocolloid and silicone seals: a survey.

Most stoma flanges are made of hydrocolloid material. Hydrocolloid is a hydrophilic material that attracts water, potentially resulting in moisture becoming trapped between the flange and skin. Also, as hydrocolloids are absorbent, the material breaks down over time, and there is a risk that some of the adhesive can remain on the skin on removal. Unlike hydrocolloids, silicone comprises fully cross-linked silicone polymers whose properties have been engineered to manage moisture without breaking down (i.e. manage the transepidermal water loss (TEWL)). A questionnaire survey was undertaken to determine ostomates' perceptions of silicone versus hydrocolloid stoma care products (both flanges and seals). The survey was sent to 229 ostomates who had used silicone seals, of whom 78 returned it (a response rate of 34%). The results suggest that use of the silicone seals resulted in a improvement in the condition of the peristomal skin condition, reduced leakage and increased wear time. Further research into this area is required.

Evaluation of a new ostomy mouldable seal: an international product evaluation.

A new mouldable seal, Brava® Protective Seal, was evaluated by patients on aspects related to residue, durability, and preference. A total of 135 patients from four countries participated (Denmark, Germany, Japan and the USA) and the new product was compared to the patients' usual pouching systems. Less residue and easier skin cleansing was observed, which may benefit patient quality of life. The possible benefits of less residue for peristomal skin health need further investigation.

Evaluación de las mejoras en dispositivos para ostomías de dos piezas con acoplamiento adhesivo / Assessment of the improvement in two-piece ostomy systems with adhesive coupling

OBJETIVO: evaluar el grado de satisfacción de los pacientes con Easiflex® Confort para colostomías e ileostomías, después de haber introducido mejoras en el diseño del disco adhesivo. METODOLOGÍA: estudio observacional, abierto y multicéntrico. Se seleccionaron aquellos pacientes ostomizados que ya se encontraban utilizando la nueva gama de productos Easiflex® Confort durante un periodo mínimo de una semana. Cada paciente incluido en el estudio recibió una única visita, durante la cual el investigador completó junto con el paciente el cuestionario para evaluar la seguridad, comodidad y adaptación después de haber usado la nueva gama de dispositivos Easiflex® Confort. Se evaluaron dos tipos de disco adhesivo (plano y convexo), así como bolsas abiertas y cerradas. RESULTADOS: el estudio se realizó en un total de 128 centros en España con una muestra de 447 pacientes. Un 91% considera que el nuevo Easiflex® Confort es muy fácil o fácil de adaptar al contorno del abdomen. Un 79% está muy satisfecho o satisfecho con la seguridad proporcionada por el dispositivo y el 85% se manifiesta muy satisfecho o satisfecho con la comodidad del mismo. Un 83% de los pacientes se muestra muy satisfecho o satisfecho con la adaptabilidad del dispositivo a los movimientos corporales. La evaluación global de Easiflex® Confort fue muy positiva, obteniendo un 81% de pacientes muy satisfechos o satisfechos con el nuevo producto, y un76% indicó su intención de seguir utilizando el dispositivo testado. DISCUSIÓN Y CONCLUSIONES: Easiflex® Confort ha demostrado comportarse como un dispositivo de elección para usuarios que buscan el máximo grado de flexibilidad y adaptación del disco adhesivo al contorno del abdomen, sin renunciar a las características de seguridad de los dispositivos de dos piezas

OBJECTIVE: to assess the level of patient satisfaction with Easiflex® Confort for colostomy and ileostomy, after making improvements in the design of the adhesive wafer. METHODOLOGY: an observational, open and multicenter study, including those ostomized patients who were already using the new range of Easiflex® Confort products during a minimum period of one week. Each patient included in the study received one single visit, during which the researcher completed with the patient the questionnaire for assessing the safety, convenience and adaptation after having used the new range of Easiflex®Confort systems. Two types of adhesive wafers (flat and convex) were assessed, as well as open and closed pouches. RESULTS: the study was conducted in 128 centres in Spain, with447 patients in total. A 91% considered that the new Easiflex®Confort is very easy or easy to adapt to the abdominal contour. A79% of patients were very satisfied or satisfied with the safety provided by the system, and 85% of patients declared being very satisfied or satisfied with its convenience. An 83% of patients were very satisfied or satisfied with the adaptability of the system to body movements. The overall evaluation of Easiflex® Confort was very positive, with 81% of patients very satisfied or satisfied with the new product; and 76% stated their intention to continue using the system tested. DISCUSSION AND CONCLUSIONS: Easiflex® Confort has demonstrated performing like a system of choice for users looking for the maximum level of flexibility and adaptation of the adhesive wafer to the abdominal contour, without giving up the safety characteristics of two-piece systems

Evaluación clínica de los nuevos dispositivos de tres piezas para ostomías Alterna® Confort / No disponible

OBJETIVO: evaluar la flexibilidad y seguridad de los nuevos dispositivos para ostomías de la gama Alterna® Confort tres piezas, así como el grado de satisfacción global de los pacientes con el nuevo dispositivo. MÉTODO: estudio observacional, abierto y multicéntrico en condiciones asistenciales reales para estudiar la nueva y mejorada gama de productos Alterna® Confort tres piezas con enganche mecánico clic. Consta de dos visitas donde profesional y paciente cumplimentan un cuestionario basal el día de la inclusión y otro final después de una semana de prueba del producto en estudio.RESULTADOS: datos recogidos de 283 pacientes. Un 36,5% colostomizados, 47,5% ileostomizados y 16% urostomizados. Relativo a las mejoras del disco, un 87,2% opina que la adhesividad es muy buena o buena, un 85% está muy satisfecho o satisfecho con la flexibilidad, un 83,9% dice estar muy satisfecho o satisfecho respecto a la seguridad. Un 87,3% están muy satisfechos o satisfechos con el nuevo cierre clic. Los pacientes valoran de manera global el dispositivo con una nota de 8,32 puntos sobre 10; además el nuevo disco mejora la piel en aquellos casos donde hay problemas periestomales, existiendo para ambas premisas una diferencia estadísticamente significativa frente a la valoración del dispositivo anterior. CONCLUSIONES: solo tras una semana de estudio, los dispositivos Alterna® Confort tres piezas demuestran un alto grado de flexibilidad y seguridad en pacientes ostomizados, así como una valoración muy positiva por parte de los profesionales sanitarios en cuanto a su adaptabilidad a pliegues y zonas difíciles, por lo que se confirma que este nuevo dispositivo es una buena alternativa terapéutica para aquellos ostomizados que precisen de un dispositivo múltiple

OBJECTIVE: to assess the flexibility and safety of the new improved devices in the three-piece Alterna® Confort range, as well as the level of overall satisfaction of patients with the new device. METHOD: an observational, open and multicenter study in a real patient care scenario, in order to study the new and improved range of three-piece Alterna® Confort devices with mechanical click fastening. The study involved two visits, where the professional and the patient completed a basal questionnaire on the day of inclusion, and a final one after one week of trying the product studied. Outcomes: data were collected from 283 patients: 36.5% with colostomy, 47.5% with ileostomy, and 16% with urostomy. Regarding the improvements in the flange, 87.2% of patients believed that adhesion was very good or good, 85% of patients were very satisfied or satisfied with its flexibility, and 83.9% stated that they were very satisfied or satisfied in terms of its safety. An 87.3% of patients were very satisfied or satisfied with the new click fastening. Patients evaluated the device in general with an 8.32 score out of 10; besides, the new flange improved the skin in cases of peristomal problems, and there was a statistically significant difference for both premises compared with the value assigned to the former device. CONCLUSIONS: after one single week of study, the three-piece Alterna® Confort devices demonstrated a high level of flexibility and safety in ostomized patients, as well as a very positive evaluation by healthcare professionals regarding its adaptability to folds and difficult areas. Therefore, it was confirmed that this new device is a good therapeutical alternative for those patients who require a multiple device