CP338 - The ATTRACT-I Clinical Investigation
Research type
Research Study
Full title
CP338: The ATTRACT-I Study - A randomized conTrolled clinical inves-Tigation evaluating a flat ostomy barRier with A novel skin pro-teCtion Technology.
IRAS ID
299660
Contact name
Carri Browne
Contact email
Sponsor organisation
Coloplast A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 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. In fact, the primary cause of peristomal skin complication development is due to leakage of ostomy effluents under the adhesive barrier. Some of the common clinical signs of peristomal skin complications include pain, itching, burning, discoloration, bleeding, and wounds . To overcome this, Coloplast A/S has developed a new baseplate which is comprised of a protective layer.
The aim of this investigation is to evaluate the performance and safety of an ostomy baseplate with a novel skin protection technology and its ability to reduce peristomal skin complications compared to SenSura® Mio.
The primary objective is to investigate whether an ostomy baseplate with a novel skin protection technology can reduce peristomal skin complications compared to SenSura® Mio. The secondary objective is to evaluate whether an ostomy baseplate with a novel skin protection technology can improve health-related quality of life of people with an ileostomy or colostomy with liquid fecal output.
This investigation is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation, with two test periods. In total 82 subjects will be included and randomised, and each subject will have at least three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days; thus approximately 70 days. The subjects will test the non-CE marked investigational product and the comparator product in a randomised order.
Subjects with an ileostomy or colostomy with liquid fecal output, currently using a flat baseplate. A total of 82 subjects will be included and randomized. The subjects will be included by competitive recruitment in up to 10 sites in five different countries (UK, Germany, Sweden, Norway, and Denmark).
REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0395
Date of REC Opinion
4 Aug 2021
REC opinion
Further Information Favourable Opinion