PURPOSE: The aims of this study were to (1) describe the demographic and clinical characteristics of the individuals with peristomal skin complications (PSCs); (2) describe the PSCs; (3) examine the relationship of PSC occurrence and severity with possible risk factors, and (4) describe how PSCs were managed clinically. DESIGN: Secondary analysis of data from randomized controlled study, the ADVOCATE trial. SUBJECTS AND SETTING: Study participants (n = 153) were divided into 2 groups: those who did not experience a PSC (n = 80) and those who did (n = 73). A participant was considered to have sustained a PSC during the original study if his or her Discoloration, Erosion, and Tissue score increased above the baseline score. METHODS: Demographic and pertinent characteristics of participants with and without PSCs were compared. In addition, data from the 73 participants who sustained PSCs were further analyzed to characterize and describe the PSCs, to investigate potential risk factors associated with the occurrence and severity of a PSC, and for clinical management. Group comparisons were made via t tests for continuous variables, χ2 test or Fisher exact test for categorical variables, and generalized linear models for identification of risk factors. RESULTS: The majority of the PSCs were mild or moderate in nature, and they were most commonly categorized by the investigators as irritant dermatitis. Two risk factors were associated with an increased likelihood of experiencing a PSC: stoma duration and peristomal skinfold or creases. Within the study period, the odds of sustaining a PSC increased over time and the presence of skinfolds or creases increased the likelihood of PSCs. Peristomal skin complication severity was likely to be worse with an ileostomy and less severe as stoma duration increased. Products used to manage PSCs consisted of barrier rings/seals, skin barrier powder, and paste or paste strips. CONCLUSIONS: Ileostomy is associated with higher risk of a severe PSC and peristomal skin creases or folds. Patient follow-up should be on a structured schedule beyond the first few weeks after surgery because the likelihood of getting a PSC increases over time. This approach may help improve outcomes, particularly for those with an ileostomy and challenging skin contours.

Background: this study examined the health-related quality of life (HRQoL) and wellbeing of people in the Netherlands who had undergone ostomy surgery. Aims: to assess how an ostomy population perceives their HRQoL and determine key stressors that influence HRQoL in this population. Methods: a cross-sectional survey, including the City of Hope National Medical Center Quality of Life Questionnaire for patients with an ostomy and a Visual Analogue Scale measuring HRQoL, was used to evaluate postsurgical patients. Findings: people with an ostomy in the Netherlands have a generally positive HRQoL, but this may be affected by peristomal skin irritation, experience of leakage on to the peristomal skin and whether their surgery was planned. Conclusions: access to specialist nurse support and products designed to prevent leakage and prevent skin irritation—two key drivers of HRQoL—may be able to maximise an individual's health status throughout their lifelong journey as a person with an ostomy.

PURPOSE:To assess the cost-effectiveness of a ceramide-infused skin barrier (CIB) versus other skin barriers (standard of care) among patients who have undergone ostomy creation.DESIGN:Cost-effectiveness analysis, based on a decision-analytic model that was estimated using data from the ADVOCATE (A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact) trial, which investigated stoma-related healthcare costs over 12 weeks among patients who recently underwent fecal ostomy, and from other sources.SUBJECTS AND SETTING:Analysis was based on a hypothetical cohort of 1000 patients who recently underwent fecal ostomy; over a 1-year period, 500 patients were assumed to use CIB and 500 were assumed to use standard of care.METHODS:We adapted a previous economic model to estimate expected 1-year costs and outcomes among persons with a new ostomy assumed to use CIB versus standard of care. Outcomes of interest included peristomal skin complications (PSCs) (up to 2 during the 1-year period of interest) and quality-adjusted life days (QALDs); QALDs vary from 1, indicating a day of perfect health to 0, indicating a day with the lowest possible health (deceased). Subjects were assigned QALDs on a daily basis, with the value of the QALD on any given day based on whether the patient was experiencing a PSC. Costs included those related to skin barriers, ostomy accessories, and care of PSCs. The incremental cost-effectiveness of CIB versus standard of care was estimated as the incremental cost per PSC averted and QALD gained, respectively; net monetary benefit of CIB was also estimated. All analyses were run using the perspective of an Australian payer.RESULTS:On a per-patient basis, use of CIB was expected over a 1-year period to result in 0.16 fewer PSCs, an additional 0.35 QALDs, and a savings of A$180 (Australian dollars, US $137) in healthcare costs all versus standard of care. Management with CIB provided a net monetary benefit (calculated as the product of maximum willingness to pay for 1 QALD times additional QALDs with CIB less the incremental cost of CIB) of A$228 (US $174). Probabilistic sensitivity analysis was also completed; it revealed that 97% of model runs resulted in fewer expected PSCs with CIB; 92% of these runs resulted in lower expected costs with CIB.CONCLUSIONS:Findings suggest that the CIB is a cost-effective skin barrier for persons living with an ostomy.