Evaluation of a New Elastic Ostomy Appliance to Decrease Skin Complications: Results of a Pilot Study

Peristomal skin complications due to appliance leakage occur frequently in all types of ostomies with great emotional, social, and financial impact for patients. PURPOSE: This pilot study was conducted to evaluate the safety and use of a new, reusable, nonadherent, elastic device. METHOD: A convenience sample of nonhospitalized patients with ileostomies and colostomies was recruited through the Dutch ostomy patient association. Participant inclusion criteria stipulated the presence of ileostomy or colostomy, a body mass index between 18 and 30, and presence of an ostomy for at least 1 month. Patients with existing prolapse or necrosis of the ostomy, inability to give consent, or concurrent usage of other aids to prevent leakage or skin problems were excluded. Participants were fitted with and asked to wear the appliance continuously for 4 weeks and report experiences in a structured diary. Patient charts were reviewed for baseline demographic characteristics that included age, gender, American Society of Anaesthesiologists classification, and body mass index (BMI). Study nurses performed structured weekly interviews and inspections of the ostomies and peristomal skin. The primary outcome measure was occurrence of serious adverse events such as ostomy necrosis or perforation. Secondary outcome measures were patient reported incidents of leakage and satisfaction during wear and changing of the appliance. Peristomal skin complications also were recorded. Descriptive statistics were used to analyze results. In addition, subgroup analysis of patients with a parastomal hernia was performed because of the potential benefits of the device design in these cases. RESULTS: Participants included 23 patients (16 with colostomies, 7 with ileostomies); 13 participants (57%) were female). Mean age and BMI were 64 years and 28.3, respectively. Six (6) patients had a parastomal hernia. Due to shifting or discomfort while wearing the appliance, 16 participants discontinued use before the end of the study and were excluded from analysis from the point they left the study. Mean duration of participation was 12.8 days. No adverse events occurred. Mean number of incidents of leakage/ week decreased from 3.5 +/- 4.9 at start of the study to 1.8 +/- 1.3 at week 4. The mean number of pouches used/week decreased from 10.5 +/- 5.4 to 8 +/- 2.6. Peristomal skin reactions were present in 15 patients (65.2%) at start of the study and decreased to 1 patient (14.3%) at the end of the study. Patient satisfaction did not change over the course of the study. Patients with parastomal hernias had similar results. CONCLUSION: No serious adverse events were reported and leakage and skin irritation were found to improve, but participant dropout rate was high and average usage time was only 12.8 days, which limits interpretation of the results. The data suggest that the appliance may offer an (intermittent) alternative to existing ostomy materials for patients experiencing troublesome leakages, peristomal skin problems, or parastomal hernias, but further research is needed to explore these outcomes.