A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial)

Abstract

PURPOSE:To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers.DESIGN:The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design.SUBJECTS AND SETTING:The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings.METHODS:Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered.RESULTS:Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: −1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were “very satisfied” with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was noted in both groups.CONCLUSIONS:The use of a ceramide-infused barrier significantly decreased cost and increased satisfaction with patient-reported outcomes.

Complicações de estomia intestinal e pele periestoma: evidências para o cuidado de enfermagem [Complications of ostomy bowel and peristomal skin: evidence for nursing care] [Complicaciones de la ostomía intestinal y de la piel peristoma: evidencia para el cuidado de enfermeira]

“…Após a aplicação dos demais critérios de inclusão, dos 29 estudos selecionados para a leitura na íntegra, 19 compuseram a amostra da presente revisão, conforme mostra o fluxograma na Figura 1. Dos 19 estudos incluídos na revisão [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] , quatro foram desenvolvidos na Holanda, três nos Estados Unidos da América, dois na Índia, dois na China, dois na Noruega, um na Finlândia, um no Japão, um na Arábia Saudita, um na Turquia, um na Alemanha e um no Irã. O Inglês foi o idioma da totalidade dos estudos.…”

“…Na categoria barreiras de pele e equipamentos coletores utilizados para o manejo de complicações de pele periestomal, foram incluídos quatro estudos 21,23,25,27 . Esses estudos acrescentam informações sobre as barreiras de pele, seu funcionamento, sua aderência e fixação, bem como, a função de proteção contra a ação do efluente.…”

“…É valido ressaltar que a aplicação de equipamentos coletores com composições específicas pode ajudar a manter a integridade da pele. Um exemplo desses componentes é a ceramida, um lipídio natural que pode ser extraído de grãos de soja e sementes de girassol e que atua na prevenção da perda de água transepidérmica por meio da fusão no estrato córneo, formando uma camada de proteção 23 O equipamento coletor com ceramida ajuda a reduzir os custos e as complicações da pele periestomal, fornece um nível de proteção contra os efeitos prejudiciais da remoção do coletor sendo significativamente menos prejudicial à epiderme em comparação ao convencional 23,27 .…”

Factors influencing health-related quality of life of those in the Netherlands living with an ostomy

“…New and established ostomates may request home visits by a specialist nurse if they experience complications with their stoma or peristomal skin. Specialist nurses will tailor care to individuals and provide products that best address their needs, including those that are formulated to support optimal skin health, such as ostomy skin barriers that are infused with ceramide or have pH buffering technology (Colwell et al, 2018;McPhail et al, 2018). Access to clinical services and products to support skin health are central to maximising clinical outcomes as well as an individual's HRQoL.…”

Health Utility, Social Interactivity, and Peristomal Skin Status

“…A common reason for peristomal skin complications in the individual with an ostomy is leakage of ostomy effluent and repeated contacts with peristomal skin, resulting in moisture-associated skin damage, also referred to as irritant dermatitis. 3 – 5 …”