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.