Comparison of Ostomy Products (COOP)
Research type
Research Study
Full title
A randomised-controlled double-blind cross-over comparison of Manuka honey hydrocolloid (Aurum®) versus conventional hydrocolloid (Optum®) on peristomal skin health.
IRAS ID
174393
Contact name
David Voegeli
Contact email
Sponsor organisation
University Hospital Southampton NHS foundation trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Stomas are openings from the inside of the body that surgeons create to allow urine and stool to be collected on the outside of the stomach. Bags are worn to collect the stool. Skin damage around stoma sites is common.
Stoma bags are currently based on a material called a hydrocolloid. This material sometimes causes people skin problems. Hydrocolloids used in wound dressings have used honey to try to prevent the risk of infection. It is also believed that honey may reduce inflammation and help to moisturise the skin. Aurum® stoma products have been developed with Manuka honey in them to try to improve skin health and stop problems. Aurum® has been available in Europe and evidence suggests that users have fewer skin problems. There is no academic evidence to support this though.
This study will aim to assess the clinical performance of Aurum® over the Optum® hydrocolloid bags. People will try both bags as part of the study. Researchers will not know in what order people are trying the bags. People will try each bag for four weeks with a two week break in between. There will be nine visits in total for the study
People aged between 18 and 85 will be invited to take part in this study. They will need to have a stoma that is more than one year old. The skin around the stoma needs to be in good health.
There are limited risks to participants. The study team will inform the participants' GP or colostomy nurse specialist if there are any concerns. David Voegeli is the main contact for the project, Welland Medical Ltd Uk are funding the project and University Hospital Southampton Foundation Trust is acting as the sponsor.REC name
London - Stanmore Research Ethics Committee
REC reference
15/LO/1101
Date of REC Opinion
5 Aug 2015
REC opinion
Further Information Favourable Opinion