Evaluation of a Skin Barrier Ring With Assisted Flow: A Prospective Cohort Study.

PURPOSE: The purpose of this study was to assess the effect of a skin barrier ring with assisted flow in preventing peristomal skin complications (PSCs) in patients with an ileostomy and to evaluate the participants' perceptions of the device. DESIGN: Single-group, prospective cohort study. SUBJECTS AND SETTING: Both inpatients and outpatients with newly created (n = 14) or established (n = 1) ileostomies were recruited from 2 clinical sites in the United States: one was an academic teaching hospital system in the Midwestern United States and the second was a teaching hospital located in the Southeastern United States. METHODS: Participants used the skin barrier ring with assisted flow after receiving education on its use. The pouching system was changed on a routine basis as determined by the ostomy nurse specialist. The Ostomy Skin Tool (OST) was used to assess each participant's peristomal discoloration (D), erosion (E), and tissue overgrowth (T) on admission to the study (baseline) and at final assessment (60 ± 33 days). Secondary outcomes (device handling, comfort, and discretion) were assessed through a questionnaire administered during the final data collection visit. RESULTS: The mean baseline DET score among the 14 participants with a new ileostomy was 2 or less, indicating no PSCs. The incidence of PSCs in this study was 40% (n = 6). Thirteen of 15 participants (86.7%) agreed that the skin barrier ring with assisted flow was easy to apply. Fourteen (93.4%) agreed that the device was comfortable and easy to remove. All 15 participants (100%) agreed it was discreet under clothing. CONCLUSIONS: Sixty percent of participants (n = 9) using the investigational device experienced a PSC. More than 90% of participants agreed that the device was comfortable and easy to remove, and all participants (100%) agreed it was discreet when worn under clothing.

Use of a Convex Pouching System in the Postoperative Period: A National Consensus.

Convex pouching systems have been available for ostomy patients for decades; however, controversy remains over the use of convexity in the postoperative period. A group of 10 nurses and physicians with expertise caring for patients with an ostomy completed a scoping review identifying research-based evidence and gaps in our knowledge of the safety and effectiveness related to the use of a convex pouching system following ostomy surgery. Results of this scoping review demonstrated the need for a structured consensus to define best practices when selecting a pouching system that provides a secure and reliable seal around the stoma, avoids undermining and leakage of effluent from the pouching system, and contributes to optimal health-related quality of life for patients following ostomy surgery. The expert panel reached consensus on 8 statements for the use of convex products immediately after surgery and throughout the first 6 months after stoma creation, as well as describing goals in choosing the best pouching system for the patient with an ostomy.

Survey Results on Use of a Convex Pouching System in the Postoperative Period.

PURPOSE: The purpose of this study was to validate time frames for postoperative care following stoma surgery and to determine participants' current practice with convex pouching systems during the postoperative period. DESIGN: A Cross-sectional survey. SUBJECTS AND SETTING: The sample comprised 332 ostomy care specialists practicing in the United States. Most (n = 220; 66%) had more than 10 years' experience caring for patients with ostomies, 82% (n = 272) were certified WOC or ostomy care nurses (CWOCN and COCN), and 7% (n = 23) were board-certified colorectal surgeons. METHODS: A 23-item online questionnaire was created for purposes of the study. Items in the questionnaire queried professional background and experience caring for patients with an ostomy. A single item was used to identify postoperative care periods following ostomy surgery. Additional items queried current practice patterns related to use of convex pouching systems and the timing of their use. Data were collected from January 18 to February 8, 2021. RESULTS: Most respondents (n = 270; 90%) agreed with the following postoperative periods after ostomy surgery: immediate postoperative period (days 0-8); postoperative period (days 9-30); and transition phase (days 31-180). Most respondents (n = 274; 95%) indicated they would use a convex pouching system when clinically appropriate during the first 30 days following ostomy surgery and 79% (n = 228) indicated using a convex pouching system regardless of when the surgery was performed. Less than 1% (n = 2) indicated never using convexity within the first 30 days following stoma surgery, and only 3% (n = 8) indicated avoidance of convexity pouching systems in the immediate postoperative period. CONCLUSIONS: Findings indicate that use of convexity during the postoperative period is prevalent to provide a secure seal and predictable wear time.

Challenges faced by people with a stoma: peristomal body profile risk factors and leakage.

AIM: The Ostomy Life Study 2019 aimed to obtain a better understanding of the challenges faced by people with stoma. METHODS: Online survey with participants from 17 countries. FINDINGS: Of the 54 614 individuals invited to take part, 5187 responded; 62% of the respondents avoided physical and social activities because of their stoma and 37% had never consulted their stoma care nurse to have the fit of their stoma product checked. In a subgroup receiving questions on leakage (n=4209), output under the baseplate and leakage onto clothes were experienced within the previous month by 76% and 26% of respondents, respectively. Higher chance of leakage was associated with an irregular stoma shape and peristomal body profile; a stoma level at or below the skin surface; and the presence of creases, folds and other changes in the peristomal area. CONCLUSION: Leakage and access to a stoma care nurse to provide the necessary care and guidance remain important concerns for individuals with a stoma.

Ostomy Complications and Quality of Life of Ostomy Support Belt/Garment Wearers: A Web-Based Survey.

PURPOSE: The purpose of this study was to examine ostomy complications and health-related quality of life (QOL) in individuals with an ostomy who wear an ostomy support belt/garment. DESIGN: A mixed-methods descriptive study. SUBJECTS AND SETTING: Two hundred two community-living adults with an ostomy were recruited using an industry distribution list. The target sample had no geographic restrictions. METHODS: Descriptive analysis was conducted for all outcomes. Participants were separated into groups depending on type of ostomy belt or belt/garment worn or none. All categorical data were summarized using percentages and numerical data using mean ± standard deviation. Association between categorical factors was evaluated using a χ2 test and proportions of occurrences from 2 groups were compared using a 2-proportion z-test. The mean outcomes for 2 or more groups were compared using t tests or analysis of variance (ANOVA), respectively. If ANOVA showed difference among groups, post hoc analysis of group means was conducted using Tukey's Honestly Significant Difference (HSD) test. RESULTS: Two hundred two respondents completed the survey. Of the 174 participants who responded to the survey question on leakage, 157 (90%) reported experiencing leakage and 135 (77.59%) reported rash or skin irritation. Comparison of whether participants had ever experienced a leakage event was not significantly different across groups (P = .3663). Those who wore an ostomy support belt/garment reported leakage less often (less than once a month) versus respondents who wore other types of belts or no belt (n = 49, 73.13% vs n = 53, 59.55%; P = .0388). Of the 174 participants who responded to the peristomal skin question, 135 (77.59%) participants reported peristomal skin complications. Significantly fewer participants who wore an ostomy support belt/garment reported having peristomal skin irritation compared to those who wore other types of belts or no belt (69.01% vs 84.16%; P = .0080). The mean cumulative total City of Hope Quality of Life (COH QOL) Ostomy score for all participants was 6.45 ± 1.36 out of 10, with the psychosocial domain scoring the lowest at 5.67 ± 1.30 out of 10. No significant differences were observed in mean QOL domain and total scores by those who wore an ostomy support belt/garment, other type of belt/garment, and none. When comparing COH QOL mean scores and leakage frequency of more/less once a month, those who reported leakage more often had significantly worse QOL scores in all 4 domains as well as total scores: physical (P = .0008), psychological (P = .0154), social (P = .0056), spiritual (P = .0376), and total COH QOL score (P = .0018). CONCLUSION: This study provides important information related to ostomy complications and QOL associated with wearing an ostomy belt or belt/garment. The use of an ostomy support belt/garment may offer an additional intervention to decrease frequency of leakage and peristomal skin irritation and improve QOL.

The association of bowel function, participation in life activities, and quality of life in rectal cancer survivors.

PURPOSE: To evaluate whether limited participation in life activities is associated with quality of life (QOL) in rectal cancer survivors, and if so, whether this association is independent of bowel function difficulties. METHODS: We surveyed rectal cancer survivors from four healthcare systems about their QOL, bowel function, and participation in life activities. Additional demographic and clinical variables were extracted from the electronic health record. We examined independent associations between bowel function, participation in life activities, and QOL, controlling for potential confounders. We also identified factors, including ostomy status, that correlate with participation in life activities. RESULTS: Of the 527 respondents, 52% were male, 80% were non-Hispanic white, and the mean age was 63. In fully adjusted models for all rectal cancer survivors, participation in life activities was positively associated with QOL, while bowel function was not. Bowel function retained an independent association with QOL for those who previously had an ostomy and were therefore more likely to have a low rectal anastomosis. Lower participation in life activities was correlated with lower self-reported physical and cognitive function, younger age, financial difficulty, and being non-Hispanic white. CONCLUSIONS: Rectal cancer survivors' participation in life activities was strongly associated with QOL, even when controlling for numerous confounders, including bowel function. Identifying ways to improve participation in life activities may be critical to developing rehabilitative and other supportive interventions that optimize QOL among rectal cancer survivors.

Lessons Learned About Peristomal Skin Complications: Secondary Analysis of the ADVOCATE Trial.

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, χ 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.

Risk factors and treatment outcomes of peristomal pyoderma gangrenosum in patients with inflammatory bowel disease.

BACKGROUND: Insufficient data exist for peristomal pyoderma gangrenosum (PPG), which primarily affects patients with inflammatory bowel disease (IBD). AIMS: To evaluate the risk factors and treatment response of PPG in IBD patients in a real-life cohort. METHODS: Cases of PPG were identified retrospectively using ICD-9/10 codes in patients with IBD who had an ostomy at a tertiary care centre. Disease-specific characteristics were compared between groups with and without PPG, and response to therapy was evaluated in patients with PPG. RESULTS: The cohort included 41 IBD patients with PPG and 123 IBD controls with an ostomy who never developed PPG. Patients with PPG were more likely to be female (76% vs 51%, P = 0.006), had higher BMIs (29.78 ± 0.89 vs 23.53 ± 0.51, P < 0.0001) and had increased usage of pouch belts (97% vs 71%, P = 0.0008) compared to controls. There were no differences in age at surgery (41.76 ± 2.60 vs 43.49 ± 1.50, P = 0.57) or IBD diagnosis (63% vs 54% Crohn's disease, P = 0.28) between PPG and controls. 85% of PPG patients achieved complete resolution with different treatments, including surgery. Complete resolution with topical corticosteroids and calcineurin inhibitors alone were low (14% and 13% respectively). Higher rates of complete resolution were reported with anti-tumour necrosis factor (TNF) agents (63%) and surgical interventions (80%). CONCLUSIONS: Female gender, higher BMI and pouch belts were associated with increased risk of developing PPG. Most PPG cases resolved after treatment with the highest rates of complete resolution seen with anti-TNF agents and surgical intervention.

Creating consensus-based practice guidelines with 2000 nurses.

Medical professionals follow evidence-based practice guidelines to achieve effective patient outcomes. Traditionally, to develop guidelines, a small group of experts examine evidence then agree on a set of statements, which are then published in journals. However, more than 7000 primary care journal articles are published monthly. This study examined a different way of drawing up practice guidelines, which involved large numbers of nurses from different countries directly in developing then disseminating the guidelines to speed up acceptance and the implementation of best practice. The results were consensus-based best practice guidelines for the treatment of patients with ostomies, which have received a high level of acceptance and enthusiasm from practitioners in 27 countries.

International Consensus Results: Development of Practice Guidelines for Assessment of Peristomal Body and Stoma Profiles, Patient Engagement, and Patient Follow-up.

Evidence indicates that a common problem for the person with an ostomy is pouch leakage and the development of peristomal skin irritation, which can negatively affect quality of life. While it is clear that the pouching system seal leakage can cause profound problems for the person with an ostomy, little information is available on interventions that focus on leakage. To address this gap, an international group of ostomy nurse experts was convened to develop consensus-based practice guidelines to assist ostomy nurses in determining the best pouching system for the patient. The outcomes of these guidelines for the person with a stoma are to decrease leakage and increase security and confidence leading to an increased quality of life. A large-scale Modified Delphi Consensus-Building Process was used to identify key factors in assessing body and stoma profiles to determine the best pouching system. The resulting consensus provides practice guidelines on how to assess body and stoma profiles, engage and educate patients, and when to follow up with patients after hospital discharge or product change.

Recovering from Cystectomy: Patient Perspectives.

BACKGROUND: Bladder cancer patients who undergo cystectomy and urinary diversion face functional and quality-of-life challenges. Little is known about these patients' experiences during decision-making, surgery, and recovery, or how they vary by treatment setting. OBJECTIVE: To learn about patients' experiences with treatment choice, surgical care, and recovery across health settings. Understanding patient experiences is essential to closing care gaps and developing patient-reported measures. METHODS: We conducted focus groups with cystectomy patients and family caregivers at a large comprehensive health care system (N = 32 patients) and an NCI-designated comprehensive cancer center (N = 25 patients and 5 caregivers). Using standard qualitative methods, we identified themes that are not well-represented in existing research. RESULTS: Across both systems, patients described variable experiences in decision-making about their cystectomy and urinary diversion. Some felt overwhelmed by information; others felt poorly informed. Many found self-care equipment challenging; many felt they knew little about what to expect regarding chemotherapy, recovery, and transitioning home. At times, health care personnel could not help manage patients' ostomies or catheterization equipment. Our study also contributes a grounded theoretical framework for describing meaningful domains of patient experience with cystectomy and urinary diversion. We identified a common trajectory that includes decision-making, surgery and post-operative recovery, mastery of self-care, and reintegration. CONCLUSIONS: Patients with radical cystectomy and urinary diversion report a wide variety of experiences not captured by quantitative measures. These findings demonstrate that many cystectomy patients could benefit from additional post-operative support. We offer a framework to measure patient-centered domains in future research.

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

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.

Costs of an ostomy self-management training program for cancer survivors.

OBJECTIVE: To measure incremental expenses to an oncologic surgical practice for delivering a community-based, ostomy nurse-led, small-group, behavior skills-training intervention to help bladder and colorectal cancer survivors understand and adjust to their ostomies and improve their health-related quality of life, as well as assist family caregivers to understand survivors' needs and provide appropriate supportive care. METHODS: The intervention was a 5-session group behavior skills training in ostomy self-management following the principles of the Chronic Care Model. Faculty included Wound, Ostomy, and Continence Nurses (WOCNs) using an ostomy care curriculum. A gender-matched peer-in-time buddy was assigned to each ostomy survivor. The 4-session survivor curriculum included the following: self-management practice and solving immediate ostomy concerns; social well-being; healthy lifestyle; and a booster session. The single family caregiver session was coled by a WOCN and an ostomy peer staff member and covered relevant caregiver and ostomate support issues. Each cohort required 8 weeks to complete the intervention. Nonlabor inputs included ostomy supplies, teaching materials, automobile mileage for WOCNs, mailing, and meeting space rental. Intervention personnel were employed by the University of Arizona. Labor expenses included salaries and fringe benefits. RESULTS: The total incremental expense per intervention cohort of 4 survivors was $7246 or $1812 per patient. CONCLUSIONS: A WOCN-led group self-help ostomy survivorship intervention provided affordable, effective, care to cancer survivors with ostomies.

Intestinal Stomas-Postoperative Stoma Care and Peristomal Skin Complications.

Intestinal stomas are necessary for several colon and rectal conditions and represent a major change in the new ostomate's daily life. Though dehydration is the most frequent etiology requiring readmission, irritant contact dermatitis and a host of other peristomal skin conditions are more common complications for ostomates. Wound, ostomy, and continence nurses are invaluable resources to both ostomy patients and providers. A few simple interventions can prevent or resolve most common peristomal complications. Good stoma care is possible in a resource-poor environment.

North America Wound, Ostomy, and Continence and Enterostomal Therapy Nurses Current Ostomy Care Practice Related to Peristomal Skin Issues.

PURPOSE: The purpose of this study was to describe the practice of 796 ostomy nurses in North America in 2014 related to peristomal skin issues. DESIGN: Descriptive study. SUBJECTS AND SETTING: Participants were 796 wound, ostomy, and continence (WOC) and enterostomal therapy (ET) nurses currently practicing in the United States or Canada and caring for patients with ostomies. The collection of data occurred in conjunction with an educational program on peristomal skin complications and practice issues and solicited the participant's perception on the incidence and frequency of peristomal skin issues as well as on practice patterns. METHODS: Participants attended an educational program. They were also asked to anonymously respond to multiple-choice questions on ostomy care management via an audience response system followed by discussion of each item and their responses. This descriptive study reports on the answers to the questions as well as the pertinent discussion points. RESULTS: Participants estimated that approximately 77.70% of their patients developed peristomal skin issues. The most commonly encountered problem was irritant contact dermatitis (peristomal moisture-associated skin damage). Contributing factors were inappropriate use of a pouching system owing to lack of follow-up after hospital discharge. Reported interventions for the prevention and management of peristomal skin issues included preoperative stoma site marking, use of a convex pouching system, and barrier rings. However, subsequent discussion revealed that the frequency of use of these products varied considerably. Participants identified shortened hospital stays, absence of preoperative stoma marking, and limited outpatient follow-up as contributing to development of peristomal skin problems. CONCLUSION: WOC and ET nurses estimate that more than three-quarters of persons living with an ostomy develop peristomal skin problems. Multiple interventions for managing these problems were identified, but some variability in management approaches emerged.

Outcome Criteria for Discharging the Patient With a New Ostomy From Home Health Care: A WOCN Society Consensus Conference.

The Wound, Ostomy and Continence Nurses Society hosted a consensus panel of expert ostomy clinicians who were tasked with identifying minimal discharge criteria for home care patients with a new fecal or urinary diversion. Shortened hospital inpatient stays, higher patient acuity, and limited access to ostomy specialists send patients with new ostomies home with multiple educational and adjustment needs related to a new stoma. The Society recognized the lack of evidence-based ostomy practice and supported the work of the panel to develop statements that defined elements of the care plan for the patient or caregiver in home care who is adapting to living with a stoma. Eighteen statements were developed that provide minimum discharge criteria for the patient with a new ostomy in the home care setting. Support based upon current evidence as well as expert opinion with implementation strategies are offered for each statement.

Management Approaches to Stomal and Peristomal Complications: A Narrative Descriptive Study.

PURPOSE: The purpose of this study was to identify optimal interventions for selected complications based on WOC nurse experts' judgment/expertise. METHODS: A cross-sectional quantitative descriptive design with qualitative, narrative-type components was used for this study. Following validation rating of appropriateness of interventions and quantitative rankings of first-, second-, and third-line approaches, participants provided substantive handwritten narrative comments about listed interventions. Comments were organized and prioritized using frequency count. RESULTS: Narrative comments reflected the quantitative rankings of efficacy of approaches. Clinicians offered further specific suggestions regarding product use and progression of care for selected complications. CONCLUSIONS: Narrative analysis using descriptive quantitative frequency count supported the rankings of most preferred treatments of selected stomal and peristomal complications. Findings add to the previous research on prioritized approaches and evidence-based practice in ostomy care.