Search Results (9)

Background/Objectives: Ostomy creation surgery is a common intervention for patients with conditions such as colorectal cancer, ulcerative colitis, Crohn’s disease, or acute events like trauma and gastrointestinal perforation. Individuals with an ileostomy face unique challenges when managing their new ostomies due to the liquid caustic nature of the effluent, increasing the likelihood of leakage and peristomal skin complications (PSCs). This sub-analysis evaluates the prevalence of leakage and PSCs in a cohort of individuals with a new ileostomy and examines the risk of leakage of different ostomy pouching systems and their impact on leakage and PSCs. Methods: This sub-analysis examined a cohort of 98 patients from a previously published retrospective chart review of stoma-creation surgeries at the University of Pittsburgh Medical Center. Data on pouching system selection, leakage, and PSCs were collected from electronic medical records and evaluated across 479 pouch changes. Two main barrier pouching systems were analyzed: elastic tapeless border (ETB) and ceramide-infused tape-border (CIB) barriers. Statistical analyses using generalized linear mixed models assessed the risk of leakage for each barrier type and controlled for significant differences in the sub-groups. Results: The prevalence of leakage in the ileostomy cohort was 19%, with the prevalence of leakage increasing over successive pouch changes. The ETB sub-group experienced a significantly lower risk of leakage (13.7%) compared to CIB (29.3%), reflecting a 53.2% lower risk of leakage with ETB (p = 0.03; OR 2.45). Conclusions: This sub-analysis of ileostomy patients confirms that ETB significantly reduces the risk of leakage in this more difficult to manage population compared to CIB, a clinically important consideration in PSC development and overall ostomy management. Evidence-based selection of ostomy barriers can improve patient outcomes, enhance quality of life, and reduce healthcare resource utilization. Full article

Background/Objectives: Peristomal skin complications (PSCs) are common among patients with ostomies, significantly impacting quality of life and increasing healthcare utilization. This study aimed to evaluate the effects of the Dermamecum protocol, a risk-stratified educational intervention, on the prevention of PSCs, self-care improvements, health-related quality of life (HRQoL), and patient satisfaction over a 90-day follow-up period. Methods: This prospective cohort study included 305 patients stratified into three risk-based groups (green, yellow, and red paths) according to the Dermamecum protocol. Primary outcomes included PSC rates at 30, 60, and 90 days. Secondary outcomes included self-care scores, HRQoL, and patient satisfaction. Comparative analyses and trend assessments were performed across groups and time points. Temporal trends in PSCs were analyzed using Poisson regression. Results: Early PSC rates were 8.5% at 30 days, with late complications at 7.9% and 6.2% at 60 and 90 days, respectively. No significant differences in PSC rates were observed between paths. Self-care scores improved over time, with stability across groups and domains. HRQoL remained stable, with minor fluctuations in physical and mental components. Patient satisfaction was high across all paths. Poisson regression identified significant temporal trends in PSC rates, with higher risks at 30, 60, and 90 days compared to baseline. Age, BMI, and path assignment (lower risk for the green path) were significant predictors of PSCs. Conclusions: The Dermamecum protocol effectively maintained low PSC rates, supported self-care, and sustained HRQoL and patient satisfaction. These findings highlight the value of risk-stratified, patient-centered interventions in ostomy care. Further studies are needed to validate these results and explore long-term outcomes. Full article

People who have gone through stoma surgery face different problems and difficulties every day, although most of these issues improve significantly with time. The quality of life of ostomy patients has been proven to be strictly related to self-care ability. So, it is essential for patients to properly maintain the ostomy site, including proper daily self-care and regeneration of the skin around the stoma, to avoid stoma-related complications. This review was undertaken using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. The main aim of the literature review was to analyse and present the characteristics of medical products used in ostomy care currently existing on the market. The intervention and management of stoma problems with appliances and accessories are also summarised. This literature review is limited to a critical analysis of the scientific and professional literature and informational materials developed by manufacturers of stoma accessories. Full article

Objective: It is well established that having a stoma can negatively impact health-related quality of life (HRQoL), but there is a paucity of research describing the natural history of certain complications associated with living with a stoma, such as leakage and peristomal skin complications (PSCs), and whether these affect QoL within the first year of stoma surgery. The objective of this study was to investigate the pattern of such complications and impact on QoL in individuals who had stoma surgery within the preceding year. Methods: A cross-sectional study was conducted at three hospital sites in the United Kingdom to evaluate the burden of disease in those who had undergone intestinal stoma formation surgery within the preceding year. The study consisted of a one-to-one consultation with a study nurse and the completion of an online questionnaire by the patient (ISRCTN-registry: 23080097). The nurse-led interview directly evaluated peristomal skin health, whilst the online questionnaire evaluated the impact of leakage (using the Ostomy Leak Impact tool), generic mental well-being (by WHO-5) and wider HRQoL (by EQ-5D-5L). Results: A total of 114 individuals with an intestinal stoma completed the evaluations. The participants had a mean age of 55.8 years (range 18–87 years) and 58% were male. Forty-three percent of the participants had experienced leakage of stomal effluent outside the baseplate (e.g., onto clothes) in the preceding two weeks and 85% suffered from PSCs ranging from mild (35%), to moderate (18%), and severe (32%). Leakage and PSCs were associated with lower mental well-being and HRQoL (p < 0.05). Leakage events, HRQoL, mental well-being and peristomal skin health were similar for individuals across different timepoints from the time of surgery within the first year. Conclusions: This study reported a high disease burden in people with a new intestinal stoma. Experiencing frequent leakage incidents and/or living with severe PSCs were associated with reduced HRQoL and mental well-being. Full article

Background: Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside the baseplate on a monthly basis. Leakage has additional physical and psychosocial consequences, for instance, peristomal skin complications, feeling unable to cope, and self-isolation. Method: An interventional, single-arm, multi-centre study was undertaken in the United Kingdom to evaluate a novel digital leakage notification system for ostomy care, including a support service (=test product) for 12 weeks in patients with a recent stoma formation (≤9 months). Patients completed questionnaires at baseline and after 4, 6, 8, 10, and 12 weeks, evaluating leakage episodes, Ostomy Leak Impact (tool containing three domains), and patient self-management (by PAM-13). Additionally, mental well-being (by WHO-5) and health-related quality of life (QoL) (by EQ-5D-5L) were assessed. Outcomes between baseline and final evaluation were compared by generalised linear and linear mixed models. Results: 92 patients (ITT population) with a mean age of 49.4 years (range 18–81 years) were recruited. Of these, 80% had an ileostomy, and 53% were female. After 12 weeks of using the test product, a significant decrease in mean episodes of leakage outside the baseplate (1.57 versus 0.93, p < 0.046) was observed. Ostomy Leak Impact scores improved across all three domains (p < 0.001), indicating less embarrassment, increased engagement in social activities, and increased control. Patient self-management also improved significantly (PAM-13 score: ∆6.6, p < 0.001), as did the WHO-5 well-being index (∆8.0, p < 0.001). Lastly, EQ-5D-5L profile scores tended to improve (p = 0.075). Conclusions: A new digital leakage notification system demonstrated strong improvements to patients’ stoma self-care, mental well-being, and QoL. Registration number on ClinicalTrials.gov: NCT05135754. Full article

This study, employing an interim analysis, investigates the effects of the Dermamecum protocol, a structured educational and tailored approach that stratifies ostomy patients into risk paths (green, yellow, red) based on pre-operative and post-operative characteristics. The green path indicates a low risk of peristomal skin complications (PSCs), focusing on sustaining healthy behaviours and basic stoma care. The yellow path represents a moderate risk, emphasizing the need for patients to self-monitor and recognize early signs of complications. The red path corresponds to high risk, requiring stringent monitoring and immediate access to healthcare support. The study aims to reduce PSCs and improve patient outcomes. Methods include the stratification of 226 patients, with significant differences in gender distribution, BMI categories, and stoma types across the paths. Results show an occurrence rate of PSCs of 5.9% in all risk paths (5.7% green path, 4.7% yellow path, and 7.9% red path, p = 0.685), significantly lower than the median rate of 35% reported in the literature. Multiple correspondence analysis validated the stratification, with distinct clusters for each path. Poisson regression models in the exploratory framework of an interim analysis identified male gender as the only significant predictor of PSCs, indicating the need for gender-specific interventions. The findings suggest that the Dermamecum protocol effectively reduces early PSCs, providing a foundation for further research. Full article

Patients with a stoma are at risk of developing peristomal skin complications (PSCs) that can negatively impact their quality of life. This study aims to identify potential risk factors for dermatitis, pruritis/xerosis, infections, and ulcerations among patients with a stoma and evaluate preventive measures. This cross-sectional study involved data regarding 232 Italian patients with a stoma. A questionnaire was used to collect patient characteristics, comorbidities, and stoma management data. The most frequent PSCs observed were dermatitis and pruritis/xerosis in approximately 60% of patients. Psoriasis was strongly correlated with dermatitis, while being overweight or obese increased the risk of pruritis/xerosis. Class 2 obesity and atopic dermatitis were associated with an increased risk of infections. Being underweight, completely nonautonomous, and having inflammatory bowel disease were associated with a higher risk of ulcerations, while radiotherapy was a strong risk factor for ulceration. Preventive measures such as using hydrocolloid barriers, TNT gauze cleansing, and low pH detergent were effective in preventing dermatitis. Appropriate stoma care and maintenance, including the use of protective film and careful monitoring of weight and comorbidities, are crucial in minimizing the risk of complications associated with a stoma. Full article

In order to determine the perception of ostomized patients about the performance and safety of the new one-piece device Moderma Flex, as well as the evolution of peristomal skin health after its use. The pre- and post-experimental multicenter study after the use of the Moderma Flex one-piece ostomy device on 306 ostomized people from 68 hospitals in Spain. We used a self-made questionnaire on the usefulness of different parts of the device and the perception of peristomal skin improvement. The sample was composed of 54.6% (167) men and had an average age of 64.5 years (standard deviation = 15.43). The type of device most commonly used according to its opening was closed by 45.1% (138). In addition, for the type of barrier, the most frequently used is the flat one; 47.7% (146) and 38.9% (119) used a model of soft convexity. A total of 48% scored with the highest assessment in the perception of skin improvement. The percentage of patients with peristomal skin problems decreased from 35.9% at the first visit to less than 8% after the use of Moderma Flex. Further, 92.4% (257) had no skin problems, the most frequent being erythema. The use of the Moderma Flex device seems to be related to a reduction in peristomal skin complications and a perception of improvement. Full article

Background: Peristomal skin complications (PSCs) are the most common skin problems seen after ostomy surgery. They have a considerable impact on a patient’s quality of life and contribute to a higher cost of care. Methods. A systematic review was conducted, querying three databases. The analysis was performed on international studies focused on the clinical-epidemiological burden of PSCs in adult patients with ileostomy/colostomy. Results: Overall, 23 studies were considered. The main diseases associated with ostomy surgery were rectal, colon and gynecological cancers, inflammatory bowel diseases, diverticulitis, bowel obstruction and intestinal perforation. Erythema, papules, skin erosions, ulcers and vesicles were the most common PSCs for patients with an ostomy (or stoma). A PSCs incidence ranging from 36.3% to 73.4% was described. Skin complications increased length of stay (LOS) and rates of readmission within 120 days of surgery. Conclusions: PSCs data are still limited. A knowledge of their burden is essential to support health personnel and decision-makers in identifying the most appropriate responses to patients’ needs. Proper management of these complications plays a fundamental role in improving the patient’s quality of life. A multidisciplinary approach, as well as increased patient education and their empowerment, are priority measures to be implemented to foster a value-based healthcare. Full article