Peristomal skin complications are a common problem for persons with an ileostomy. Purpose: The purpose of this pilot study was to solicit user feedback and perform an initial assessment of the performance of a new barrier seal designed to decrease the risk of chemical-induced dermatitis. Methods: Seven (7) potential participants who were at least 18 years of age, >6 months post surgery, with an end or loop ileostomy and unbroken peristomal skin, and who were capable of changing their appliance themselves or had the availability of care assistance were identified and recruited by the stoma care nurse at the University Hospital, Limerick, Ireland. At the initial visit and after 1 and 2 weeks, participants were asked to rate device comfort, security, and handling; skin condition was assessed by the research nurse using the Ostomy Skin Tool. Descriptive statistics were used to tabulate the results. Results: Five (5) participants completed the study. Discoloration, erosion, and tissue overgrowth scores improved in 3 of 5 patients, and the mean Ostomy Skin Tool score decreased from 5.4 ± 2.19 at the initial assessment to 4 ± 1.87 at the week 2 visit. Comfort, handling, and security ratings increased from a median of 8 at the beginning of the study to 10 at week 2. Conclusion: Initial patient feedback regarding the new product was positive, and skin assessment results suggest the new seal may help improve peristomal skin condition. Larger studies with longer patient follow-up are needed to confirm the results of this pilot evaluation.

Peristomal skin complications (PSCs) are a common problem and are estimated to account for more than 1 in every 3 visits to ostomy nurses.¹ Research² including the Ostomy Skin Study, conducted in Denmark (N = 82), and the Dialogue Study  (N >1000 patients and nurses), conducted across Canada, Spain, France, the UK, and Denmark, found participants with an ileostomy had the highest prevalence of PSCs compared to persons with a colostomy or ileostomy. As part of an open-label, noncomparative, multinational, post-marketing study, results by Martins et al³ among a sample of 950 people who had an ileostomy for at least 6 months found the primary cause of skin complications was chemical (or irritant contact) dermatitis (338 patients, 35.4%). In a cross-sectional study (N = 201) that included 100 patients with a colostomy, 82 with an ileostomy, and 19 with a urostomy, Herlufsen et al² reported the primary cause of skin complications was feces-induced erosion (33%), followed by maceration (20%), erythema (16%), and contact dermatitis (8.5%). Nybaek et al⁴ reported a 46% incidence of PSCs in a sample of 82 ileostomy patients; the primary cause was fecal dermatitis. 

Chemical dermatitis is a direct result of fecal contact with the skin.⁵ Despite high incidence rates, no single, ideal commercial accessory appears to be available to prevent enteric output contact on peristomal skin. It is proposed that the use of standard ostomy seals (barrier rings) for the prevention of chemical dermatitis, although effective, may not offer the perfect solution.

Researchers and clinicians have hypothesized that one potential reason for the high incidence of chemical dermatitis for ileostomy patients may be the absorbency of the hydrocolloid materials used as ostomy seals (barrier rings). Two (2) scenarios illustrate possible causes. First, effluent from the bowel absorbed by hydrocolloid material could be directed toward the patient’s peristomal skin. Ileostomy output is more liquid and corrosive than that of a colostomy; it is more alkaline and has a higher content of proteolytic enzymes.⁶ Therefore, when a hydrocolloid seal absorbs this ileostomy output it may begin to corrode the skin. Second, the hydrocolloid material swells when it absorbs the ileostomy output, subsequently losing its structural integrity and breaking down. This breakdown may compromise the security of the seal and its ability provide the peristomal skin with a barrier to ileostomy output, causing leakage and potentially chemical dermatitis. 

An additional usability issue relates to the requirement that patients know the shape and size of their ileostomy and subsequently cut a hole in their ostomy bag and/or manipulate an ostomy seal ring to fit their ileostomy in order to achieve a secure and accurate seal, which may be challenging.⁵ Improper placement or fit of the appliance can result in appliance leakage, which in turn may result in chemical dermatitis.

These scenarios offer the opportunity to innovate new medical accessories that could potentially reduce the risk of chemical dermatitis. A new ostomy seal barrier ring, the Ostoform Moldable Seal with FlowAssist Protection (Ostoform Limited, Dublin, Ireland) (see Figure 1) was developed through the School of Design in the University of Limerick, Ireland. The new product comprises 2 essential components: 1) an open, moldable hydrocolloid ring that aims to adhere to the patient’s skin and wrap around the stoma; and 2) a nonabsorbent, rubber spout with flexible side arms that aims to prevent the hydrocolloid ring from absorbing stoma effluent while facilitating the flow of effluent into the ostomy bag. 

The 2 primary aims of the new barrier seal design are to prevent the absorption of stoma effluent by hydrocolloid (which in turn prevents both breakdown of hydrocolloid and stomal output from contacting the patient’s skin) and to provide a flexible split ring with a handling tab (the spout) that makes the ostomy seal easy to apply and wrap securely around the stoma to achieve complete skin protection. This new seal design negates the requirement for definitive knowledge of the patient’s ileostomy shape and size when cutting the bag opening. The product is available in 3 inner diameter sizes (26 mm, 34 mm, and 40 mm) to accommodate individual ostomies. Figure 2 illustrates the steps for applying the new seal. 

The purpose of this study was to solicit user feedback and perform initial assessments of device performance through a single-arm, open-label, practical pilot application study conducted among a cohort of ileostomy patients. 

Study participants. Persons with an ileostomy were initially identified by the stoma care nurse in the University Hospital, Limerick, Ireland. Patients  were asked if they would be willing to participate in the study. If so, they were contacted by the research nurse and provided a patient information leaflet that described both the device and the study. Informed written consent was obtained by the research nurse before the study commenced. 

Inclusion criteria stipulated participants should be of either gender with an end or loop ileostomy, unbroken peristomal skin, >6 months post surgery, at least 18 years of age at the time of enrollment, and capable of changing their appliance themselves or with assistance. Patients with peristomal skin complications that breached the dermis were excluded. Because approximately 8 participants is an appropriate number for testing to identify key usability issues with products,⁷ 7 participants was deemed acceptable to gather user feedback and inform necessary design improvements for this study. 

Procedure. Participants were asked to wear the study seal for 2 weeks in conjunction with their own ostomy pouches. The seal was designed to work with both 1- and 2-piece collection bags. As such, patients could continue to use their own pouch rather than switch to a new type of pouch. If patients had been using an ostomy seal before participating in the study, they were asked to use the study seal instead. 

At the beginning of the study (Time in weeks [T] T0), the research nurse, who was trained in the use of the Ostomy Skin Tool (OST) by a stoma nurse, completed all stoma measurement and assessment variables (see Table 1). The size of the study seal provided to each patient was dependent on the diameter of their ileostomy. Pouch opening sizes were determined by the patient, with assistance from the research nurse, based on the size of the seal used. 

Participants were instructed on use of the device in conjunction with their existing pouch and reassessed after 1 week (T1) and 2 weeks (T2). Thereafter, they returned to their standard practice. Participants changed their bags at their own discretion, and frequency of bag changes was not recorded. 

Skin condition was assessed at each time interval by the research nurse using the validated OST.⁸ The OST is used to rate peristomal skin condition on 3 scales: discoloration (D), erosion (E) and tissue overgrowth (T), yielding the DET score. Within each scale, both the area of peristomal skin affected and the severity of the skin changes are rated (DA: discoloration area; DS: discoloration severity; EA: erosion area; ES: erosion severity). The peristomal area affected is assigned a score between 0 and 3 (eg, DA), and the severity a score between 0 and 2 (eg, DS). Each of the 3 scales has a cumulative score from 0 to 5, and these scores are summed to give a total DET score of 0 to 15,⁷ with 15 indicating the most severe condition. The validity and the intra- and internurse reliability of the OST have been demonstrated by Jemec et al.⁹

In order to obtain an indication of the participant’s perception of comfort, security, and handling of the study seal, each patient was asked to complete a questionnaire on paper, with assistance from the research nurse, to score his/her perception of comfort/security/handling on a scale of 1 to 10, with 1 being the most negative experience and 10 being the most positive experience. This questionnaire was developed specifically for the current study.

Data collection and analysis. Data were collected using paper forms. Upon completion of the trial, data then were pseudo-anonymized and transferred to a digital spreadsheet for analysis. Median scores for comfort, security, and handling; mean DET scores; and mean OST subsection scores were calculated for each time point. Changes in overall DET score and changes in OST subsection scores at each time point were determined. Paper forms were stored in a locked filing cabinet in the University of Limerick. 

Ethical considerations. The authors complied with the guidelines for conducting research in human subjects, and the study was approved by the Research Ethics Committee of the University Hospital, Limerick, Ireland. 

Of the 7 participants recruited and enrolled, 5 (2 men, 3 women) completed the study. One (1) man and 1 woman, both with a loop ileostomy, did not complete the study: 1 was elderly and indicated it would be difficult attending follow-up visits. The other opted out because he/she believed the device did not meet his/her needs. This user had multiple surgeries, a hernia, and a soft large abdomen with challenging skin contours (many folds and uneven surfaces). The participant also had a retracting stoma; upon retraction, the skin was drawn away from the device and the patient had not had success with any product, resulting in several leaks and multiple changes daily. 

Patient characteristics are provided in Table 2. The mean age of persons who completed the study was 53 (range 36–74) years. Two (2) had a loop ileostomy and 3 had an end ileostomy. The 2 patients who had been wearing an ostomy seal (barrier ring) before commencing the study both used the Eakin Slims product (Eakin Limited, Craigavon, UK). 

Summary DET scores. Individual DET scores showed all participants had a skin complication (DET total score ≥2) at each time point (see Table 3). Of the 5 participants who completed the study, 4 scored 5 or above at baseline; the 4 participants with a loop ileostomy scored 6 or above at baseline. 

The DET was lower between T0 and T2 in 3 participants and remained the same in 2 participants (see Table 3); mean DET score for the 5 participants who completed the study decreased from 5.4 ± 2.19 at T 0 to 4.6 ± 2.07 at T1 to 4.0 ± 1.87 at T 2. 

DET scores by OST subsection. Tissue overgrowth was reported as 0 at each time point. Values for DA and DS subscales were >0 at each time point. For both the EA and ES subscales, 1 participant improved from a score of 1 to 0 from T0 to T2. Mean scores for the DA, DS, EA, and ES subscales all decreased from T0 to T 2 (see Table 4). 

Comfort, handling, and security. Table 5 details the participants’ ratings for comfort, security, and handling at each time point. The median score for each characteristic was 8 at the start of the study. In all 5 participants, scores increased between T0 and T2. The lowest score for handling at T0 was 6, but this applied to a participant who dropped out of the study. 

Baseline DET scores. Martins et al³ reported ileostomy PSC rates of 66%, Herlufsen et al² reported rates of 57%, and Nybaek et al⁴ reported rates of 46%. In this purposeful sample, 100% of patients recruited had a skin complication.

Martins et al³ reported average DET scores for ileostomy patients of 2.77. In the current study, the DET score was higher at baseline (5.4 ± 2.19), decreasing to 4 ± 2.07 after 2 weeks, but the current sample size was too small to make meaningful comparisons between the current and previously published DET scores. No patients in the current study had normal skin condition at the beginning, which is likely to result in a higher overall DET score. 

Reduction in DET scores. In their review, Alvey¹⁰ reported the amount of exposure as well as character of effluent will determine the extent of peristomal irritation. Herlufsen et al² suggested the increased incidence of skin complications among ileostomy patients is because ileostomy effluent is more corrosive than colostomy effluent. The study seal was designed to prevent effluent from contacting the skin by preventing its absorption by the hydrocolloid. The average DET score decreased by 26%, suggesting the device worked as anticipated. 

The scores of 2 participants did not improve; 1 had a low DET score (2) at baseline and remained at this level at T2. The other participant started the study with a DET score of 6 and remained at that level. At baseline, 2 participants used another product and switched to the study seal during the trial. The other participants did not wear any seal before study participation. The skin condition of both participants who used a different seal improved when they switched to the study seal. 

The skin condition for participant 3 worsened at T1, increasing from a score of 2 to 3. This was found to be due to the unsuitability of the convex pouch used in combination with the device. This participant had a flat, hard abdomen. Accumulated, elevated peristomal pressure was evident on the skin due to the depth of the convex pouch plus the 3-mm thickness of the device. Once the participant changed to a nonconvex pouch, no further leaks occurred. The DET score for this participant improved from 3 at T1 to 2 at T2. 

Quantifying peristomal condition. Because the OST considers peristomal skin condition overall, it may limit assessment of chemical dermatitis — ie, factors such as mechanical dermatitis and allergies, which may have an influence on the DET score, are not considered. However, the OST was deemed an appropriate skin assessment tool to use because both intra- and internurse reliability have been demonstrated. In the current study, all data were collected by the same research nurse in order to control for interobserver variability. 

Participant assessment of the device. At the beginning of the study, participant feedback inferred the device was relatively easy to use. However, the lowest score (6) recorded for handling came from a participant who subsequently opted out of the study, suggesting that handling the device is not equally as simple for all patients and may be more difficult for a patient with a retracted stoma. Potential challenges in handling the device should be explored further. User perception ratings of the device improved further across the 2-week study time span, suggesting patients may require some time to adjust to the new product. Explanations for patient perception of the device over time should be explored further, and opportunities for further improving the usability/training of the device before initial application should be investigated. 

This was a short-duration study with a small number of participants and without a control group to gather basic clinical insights and user feedback. 

The decision to allow patients to continue to use their own pouch may have been a study limitation because it could have increased variability in study seal performance. Because the current study focused on usability, observing pouch function with the device provided useful device design feedback. Subsequent effectiveness studies may benefit from using one type of pouch. Furthermore, the frequency with which patients changed their pouch was not controlled or recorded and may have had an influence on  skin condition. It is recommended that future studies either control or monitor frequency of pouch change. Neilsen⁷ recommended a sample size ~8 patients for any usability studies; because 5 patients completed the current study, a larger study population is recommended for future evaluations. 

The purpose of this practical application pilot study was to solicit user feedback and perform initial assessments of the performance of a new ostomy seal among a cohort of ileostomy patients. Results from the 5 patients who completed the 2-week study indicated the ostomy seal, which aims to reduce levels of chemical dermatitis by incorporating a nonabsorbent layer into the product design, may have a role in managing peristomal skin complications. User feedback was generally positive with high ratings for handling, comfort, and security. Studies using a larger sample size and longer study duration are needed to confirm and further explore these findings.

Dr. Kelleher, Ms. Hunt, and Prof O’Sullivan have a financial interest in the company Ostoform Ltd (Dublin, Ireland), which is commercializing the Ostoform Seal. Enterprise Ireland (Dublin, Ireland), an Irish Government Agency that supports applied research, financially sponsored this activity under the Commercialisation Fund scheme.

Dr. Kelleher and Ms. Hunt are lead inventors of the concept and were Senior Research Fellows, School of Design; Prof Hannigan is a biostatistician and Associate Professor; Prof Coffey is a Professor of Surgery, Graduate Entry Medical School, University Hospitals Limerick and Health Research Institute; Dr Moloney is Manager; Ms. Ahern is a stoma nurse, Stoma Care Department; Ms. Conway is a research nurse, Clinical Research Support Unit, Health Research Institute; and Prof  O’Sullivan is an Associate Professor of Human Factors, School of Design — Health Research Institute, all with the University of Limerick, Limerick, Ireland. Please address correspondence to: Kevin Kelleher, PhD; email: info@ostoform.com.