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

An Open-labelled, Randomised, Controlled, Comparative, Explorative, Cross-over Study Investigating Safety and Performance of a New 1-piece Ostomy Product Compared Standard Care Ostomy Products in Subjects With Ileostomy

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.

Study Overview

• Status: Withdrawn
• Conditions: Skin Condition; Leakage
• Intervention / Treatment: Device: River; Device: Standard Care

Detailed Description

See brief summary

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

List of 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: River	Device: River; River is a new developed product with Coloplast as manufacturer
Active Comparator: Standard Care; Standard Care can have several manufacture and brand names. Standard Care is defined af the participants currently used stoma care product.	Device: Standard Care; Participants are using their own product and this procedure is called "Standard Care". Standard Care are the participants own products and may consist of several manufacturer and brand names.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Leakage underneath the baseplate	two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Carol Katte, MD, Ashford and St. Peters Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: August 18, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): February 7, 2012
• Last Update Submitted That Met QC Criteria: February 6, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: CP214OC