Investigation of a New Stoma Product for People With a Stoma — CP288  

Peristomal Skin Complication Clinical Trial

Official title: Investigation of a New Stoma Product for People With a Stoma

Status Completed

Clinical Trial Summary

The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.

Clinical Trial Description

Enrolled participant with an ileostomy or colostomy with liquid output were randomized to test either the non-Conformité Européene marked investigational product or one of the five comparators Conformité Européene marked products first and then will be crossed over to receive the opposite intervention. The participant will first be included in an information and inclusion visit (V0) and after signing all consent forms will complete three test visits (V1, V2, and V3). Each participant will be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The study is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation with two test periods. The study was conducted in four different countries (UK, Germany, Italy, and Norway) with a total of six sites participating. The study is now complete. ;

Related Conditions & MeSH terms

• Peristomal Skin Complication

• NCT number: NCT04101318
• Study type: Interventional
• Source: Coloplast A/S
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Completion date: July 17, 2020