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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448629
Recruitment Status : Withdrawn (The study was withdrawn because of problems found with the baseplate)
First Posted : October 7, 2011
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Leakage Skin Condition Device: Standard Care Device: River Not Applicable

Detailed Description:
See brief summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

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.

Primary Outcome Measures :
  1. Leakage underneath the baseplate [ Time Frame: two weeks ]

Secondary Outcome Measures :
  1. Peristomal skin condition [ Time Frame: Two weeks ]
    Measured by the Ostomy Skin Tool

  2. Security [ Time Frame: Two weeks ]
    The participants feeling of security when wearing the product, measured on a 5-point scale

  3. Handling [ Time Frame: Two weeks ]
    The participants ease of handling the products, measured on a 5-point scale

  4. Comfort [ Time Frame: Two weeks ]
    The participants feeling of comfort when wearing the product, measured on a 5-point scale

  5. Adverse events [ Time Frame: Two weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01448629

Sponsors and Collaborators
Coloplast A/S
Principal Investigator: Carol Katte, MD Ashford and St. Peters Hospital

Responsible Party: Coloplast A/S Identifier: NCT01448629     History of Changes
Other Study ID Numbers: CP214OC
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Skin Diseases