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.

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.

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.

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.

Discharge planning for a patient with a new ostomy: best practice for clinicians.

A comprehensive discharge plan for a patient with a new stoma is needed to ensure the individual receives the necessary ostomy education prior to discharge. The plan should include teaching basic skills and providing information about how to manage the ostomy (ie, emptying and changing the pouch, how to order supplies, available manufacturers, dietary/fluid guidelines, potential complications, medications, and managing gas and odor), assisting with transitions in care, and providing information about resources for support and assistance. The purpose of this best practice guideline is to provide clinicians with a brief overview of the essential elements that should be included in the discharge plan to facilitate patient education and the transition of care from hospital to home.

Stomal and peristomal complications: prioritizing management approaches in adults.

PURPOSE: The objectives of this study were to establish additional content validation data for proposed stomal and peristomal complications interventions and to identify optimal interventions for the specified complications based on experts' clinical judgment. SUBJECTS AND SETTING: Following pilot testing of the researcher-designed instrument, the survey was mailed to 1000 systematically randomly selected expert WOC nurses via a national mailing to a representative sample of participants who identified in their WOCN Society description as having ostomy certification and/or clinical expertise. Two hundred eighty-one nurses returned the survey, comprising a response rate of 28%. METHODS: A cross-sectional, quantitative descriptive design with qualitative components was used for this study. Respondents were asked to quantify degree of validity (relevance or appropriateness) of the survey's stated stomal and peristomal complications interventions. They were asked to rank interventions for each stomal and peristomal complication for being first-line (most preferred), second-line, and third-line treatment. Hand-written qualitative comments of the participants were transcribed and analyzed, and themes were derived. RESULTS: On a scale of 1 to 4, the mean score for all interventions was 3.47 ± 0.29 (relevant/very relevant, mean ± SD). The overall survey's Content Validity Index was 0.84 out of 1.00. Some items had lower mean scores and content validity index scores, especially peristomal interventions. Ranking of most preferred treatments revealed clearly preferred approaches in some clinical situations and some less so. Qualitative analysis of participants' comments about each stomal and peristomal complication intervention and about the whole instrument and research process was conducted generating positive and negative themes. CONCLUSION: The proposed stomal and peristomal interventions were rated as generally valid substantiating results of our earlier study. The ranking of most preferred treatments for stomal and peristomal complications provides, to the authors' knowledge, the world's first research support for prioritized approaches and evidence-based practice in ostomy care.

The role of obesity in the patient undergoing colorectal surgery and fecal diversion: a review of the literature.

The obese colorectal surgery patient may face several challenges, including a high risk for the development of colorectal cancer, an increased risk for complications with diverticular disease, and surgical risk factors including anastomotic leaks, inability to perform a low anastomosis, and septic complications. The purpose of this literature review was to examine available data on the implications of obesity on colorectal disease and colorectal surgery, particularly stoma surgery. Obesity has been documented as a risk factor for colorectal disease, but results of studies examining surgeryrelated problems secondary to obesity are inconsistent. However, clinicians generally believe obese patients undergoing colorectal surgery may be at higher risk of complications than their non-obese counterparts. The obese patient requiring the creation of a fecal diversion may encounter stoma-related issues such as stenosis, retraction, and inability to maintain a consistent pouching system seal. Stoma site marking can be challenging because of the large shifts in subcutaneous tissue and the inability for a person with a large abdomen to be able to visualize the stoma if the stoma is placed too low on the abdomen. Additional research to elucidate complication rates and risk factors is needed to help clinicians develop optimal plans of care.

Looking back: a review of classic ostomy literature in the WOCN society's official publication.

In recognition of the 40-year anniversary of the Journal of Wound, Ostomy and Continence Nursing, a review of ostomy-related articles in the Society's official publications was done. The goal was to find what were considered classic ostomy articles, articles that contributed to the practice of ostomy care nursing, and articles that as clinicians practicing in the late 70s we felt helped to shape the future of ostomy care nursing. The review began with the 1975 ET Journal and continued forward ending in 1990. A classic article was defined as one that described a new or unique use of an ostomy product, a new procedure that impacted ostomy practice, the evolution of evidence-based ostomy practice, concepts that would drive our future practice, and management of stoma complications. These articles are a glimpse into the unique, creative, and evolving practice that makes our ostomy specialty distinctive.

Peristomal moisture-associated skin damage in adults with fecal ostomies: a comprehensive review and consensus.

Approximately 1 million persons living in North America have an ostomy, and approximately 70% will experience stomal or peristomal complications. The most prevalent of these complications is peristomal skin damage, and the most common form of peristomal skin damage occurs when the skin is exposed to effluent from the ostomy, resulting in inflammation and erosion of the skin. Despite its prevalence, research-based evidence related to the assessment, prevention, and management of peristomal moisture-associated skin damage is sparse, and current practice is largely based on expert opinion. In order to address current gaps in clinical evidence and knowledge of this condition, a group of WOC and enterostomal therapy nurses with expertise in ostomy care was convened in 2012. This article summarizes results from the panel's literature review and summarizes consensus-based statements outlining best practices for the assessment, prevention, and management of peristomal moisture-associated dermatitis among patients with fecal ostomies.