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

This study has been withdrawn prior to enrollment.
(The study was withdrawn because of problems found with the baseplate)
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01448629
First received: August 18, 2011
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Leakage
Skin Condition
Device: Standard Care
Device: River

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Leakage underneath the baseplate [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peristomal skin condition [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
    Measured by the Ostomy Skin Tool

  • Security [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    The participants feeling of security when wearing the product, measured on a 5-point scale

  • Handling [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    The participants ease of handling the products, measured on a 5-point scale

  • Comfort [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    The participants feeling of comfort when wearing the product, measured on a 5-point scale

  • Adverse events [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: River Device: River
River is a new developed product with Coloplast as manufacturer
Other Name: River
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.

Other Name: Standard Care

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448629

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

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01448629     History of Changes
Other Study ID Numbers: CP214OC
Study First Received: August 18, 2011
Last Updated: February 6, 2012
Health Authority: United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014