CP288 Clinical Investigation, Version 1.0
Research type
Research Study
Full title
CP288: Investigation of a new stoma product for people with a stoma
IRAS ID
274141
Contact name
Carri Browne
Contact email
Sponsor organisation
Coloplast A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 12 days
Research summary
People with intestinal stomas have, despite development of better stoma products, problems with leakage induced peristomal skin complications which influence quality of life negatively. To overcome this, Coloplast A/S has developed a new baseplate which comprises of a protective layer. The aim is to evaluate whether the new baseplate can reduce peristomal skin complication induced by output.
The primary objective is to investigate whether a new baseplate comprising of a protective layer can reduce peristomal skin complications induced by output. The secondary objective is to evaluate the psychometric properties of a new clinical assessment tool for the peristomal skin condition.
This investigation is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation, with two test periods. In total, 96 subjects will be included and randomised, and each subject will have three test visits overseen by the Principal Investigator, or delegate. Each subject will be enrolled for approximately 12 weeks in total for the entire investigation, thus for a maximum of 90 days. The subjects will test the non-CE marked Investigational product and one of the five comparator investigational products in randomised order.
Subjects with an ileostomy or colostomy with liquid output, currently using a flat (e.g., non-convex/concave) baseplate will be included. The subjects will be included by competitive recruitment in up to 15 sites in five different countries (UK, Germany, the Netherlands, Italy and Norway).REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/0220
Date of REC Opinion
25 Feb 2020
REC opinion
Further Information Favourable Opinion