Ostomy Care System Usability Study
Research type
Research Study
Full title
An Innovative Medical Device for Ostomy and Wound Care Usability Study
IRAS ID
266122
Contact name
Thomas Clutton-Brock
Contact email
Sponsor organisation
Ostiques Ltd.
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
Ostique are developing a novel ostomy system for patients living with a stoma. In the UK over 200,000 patients live with a stoma after bowel surgery for inflammatory bowel disease, cancer or accidents. If the bowel cannot be reconnected the end is brought through a small hole in the abdomen and diverts waste output into a bag. The bags have changed little over the last 25 years and cause many patients embarrassment and body image problems. This study is part of an 18 month funded project to develop a novel, discrete alternative ostomy care system for temporary use when swimming, on the beach or in intimate occasions. The system has been developed with input from ostomates and stoma care staff, including testing on stoma training mannequins. In the final stages of development the research team need to see how the system works on real people undertaking everyday tasks. Participants will be asked to wear the prototype device attached to the skin of their abdomen away from the stoma. Additional testing to examine the performance of the device may be done using a 3D printed artificial stoma worn like a waistcoat and synthetic stool. This study will look at the safety and comfort of fit of the new system during normal daily activities particularly assessing attachment to the skin. The purpose of the study is to find any problems with the fit and usage of the system so these can be corrected in the design, and will help to develop the protocols for a later clinical trial.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0020
Date of REC Opinion
30 Jan 2020
REC opinion
Favourable Opinion