Randomised controlled trial to assess and compare the performance and safety of two-piece ostomy appliances

BACKGROUND: Choice of ostomy appliances is based on multiple factors including economic considerations, individual patient requirements and lifestyle. A recently launched two-piece ostomy collection device with an extended tape border is expected to provide a long wear time and increase patients' sense of security.

AIMS AND METHODS: A randomised controlled, non-blinded, cross-over study involving 38 patients (with colostomies and ileostomies) compared the test device to a similar device from the same manufacturer but without the tape border. The main objective was to assess wear time for non-inferiority as a measure of efficacy. Secondary efficacy assessment included peristomal skin condition using the DET (discolouration, erosion and tissue growth) score and patient acceptability, which was assessed through questionnaires using Likert-scale options. Safety was assessed according to the incidence and intensity of device-related adverse events, and the condition of the peristomal skin.

RESULTS AND CONCLUSION: Analysis of results in the per-protocol population showed an average wear time of 4.5 days for both devices and demonstrated non-inferiority. DET scores were similar in both groups, and both had low rates of device-related adverse events, all of which related to peristomal skin. Patients said the devices were user friendly. While the two devices are similar, some patients may find one with an adhesive tape more suited to their needs.