Skin Condition Clinical Trial
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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
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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