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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01448629
Other study ID # CP214OC
Secondary ID
Status Withdrawn
Phase N/A
First received August 18, 2011
Last updated February 6, 2012
Start date May 2011
Est. completion date July 2011

Study information

Verified date February 2012
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health Research
Study type Interventional

Clinical Trial 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.


Description:

See brief summary


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
River
River is a new developed product with Coloplast as manufacturer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Outcome

Type Measure Description Time frame Safety issue
Primary Leakage underneath the baseplate two weeks Yes
Secondary Peristomal skin condition Measured by the Ostomy Skin Tool Two weeks Yes
Secondary Security The participants feeling of security when wearing the product, measured on a 5-point scale Two weeks No
Secondary Handling The participants ease of handling the products, measured on a 5-point scale Two weeks No
Secondary Comfort The participants feeling of comfort when wearing the product, measured on a 5-point scale Two weeks No
Secondary Adverse events Two weeks Yes
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