Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy

Not Applicable

Withdrawn

• Conditions: Leakage; Skin Condition
• Interventions: Device: River; Device: Standard Care

• Registration Number: NCT01448629
• Lead Sponsor: Coloplast A/S

Brief Summary

Introduction:

It is not an illness to have an ostomy, even though it is an indication of previous serious illness, such as cancer, which is the reason for approximately 80% of all ostomy operations. Ostomies can be divided into three categories: colostomy (large intestine), ileostomy (small intestine) and urostomy (urinary tract). All require surgical redirection of the intestine or urinary tract, allowing for elimination of urine and faeces by means of an opening in the abdominal wall. For the population included in this study, subject with an ileostomy, colitis ulcerosa is the main cause for an ileostomy where a surgical removal of the colon and rectum resulting in an ileostomy in theory cures the disease.

It can be very challenging to live with an ostomy and modern ostomy products should make life as easy as possible for people with ostomies.

Leakage and peristomal skin problems have been found to have a negative effect on the quality of life for people with ostomies. The skin problems are the reason for one out of three visits to ostomy nurses and occur much more frequently in people who have had ileostomies than in those who have had colostomies. It has been observed that the prevalence of peristomal skin problems is 21-60% among people who have ileostomies, 13-35% among those who have colostomies and 21-48% among those who have urostomies.

Leakage from ostomies that comes into contact with the skin is thought to predispose the patient to peristomal skin problems. One investigation of peristomal skin problems found that 77% of cases were related to contact with faeces or urine.

There are several reasons why leakage from an ostomy occurs, such as uneven peristomal area, improper handling of the ostomy product or a problematic ostomy (its formation, its location, retraction, prolapse or hernia). The ostomy may also change size with time, which can lead to leakage, if the ostomy products are not adapted accordingly. As a general rule, a check-up of the ostomy by an ostomy nurse or a doctor together with educational support can reduce these problems. Modern ostomy products should, however, also be constantly developed in order to lessen to the greatest extent possible the risk of leakage and associated inconveniences.

Detailed Description

See brief summary

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-06
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Have given written informed consent.
• Are at least 18 years old.
• Have mental capacity to understand the study guidelines and questionnaires.
• Have had their ileostomy for at least 3 months
• Have an ileostomy with a diameter be-tween 19-40 mm.
• Are currently using a flat 1-piece product.
• Are able to change the product by them-selves or with help from a caregiver (e.g. spouse)
• Have experienced leakage under the base plate at least once a week over the last 2 weeks.

List of Exclusion criteria.

• Pregnant or breast-feeding.
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
• Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted).
• Are currently using a convex product
• Participating in other clinical studies or have previously participated in this study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
River	River	-
Standard Care	Standard Care	Standard Care can have several manufacture and brand names. Standard Care is defined af the participants currently used stoma care product.

Primary Outcome Measures

Name	Time	Method
Leakage underneath the baseplate	two weeks

Secondary Outcome Measures

Name	Time	Method
Security	Two weeks	The participants feeling of security when wearing the product, measured on a 5-point scale
Peristomal skin condition	Two weeks	Measured by the Ostomy Skin Tool
Handling	Two weeks	The participants ease of handling the products, measured on a 5-point scale
Comfort	Two weeks	The participants feeling of comfort when wearing the product, measured on a 5-point scale
Adverse events	Two weeks