Coloplast DialogueStudy

Coloplast

Status and phase: Completed; Phase 4

Conditions: Stoma

Treatments: Device: SenSura

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626821

DK175OS

Details and patient eligibility

About

The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

Full description

It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Enrollment: 3,017 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Signed informed consent before any study related activities
• Subjects with a colostomy, ileostomy or urostomy
• Subjects must have had their ostomy for at least 6 months
• Subjects must have mental capacity to understand the study and questionnaires
• Subjects must be at least 18 years of age.

Exclusion criteria

• Women who are pregnant or breast-feeding
• Subjects who have more than one ostomy
• Subjects with an ostomy who use plug
• Participation in other studies at the same time
• Previous participation in this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,017 participants in 1 patient group

1

Experimental group

Treatment:

Device: SenSura