Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
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|ClinicalTrials.gov 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Recruitment Status : Withdrawn (The study was withdrawn because of problems found with the baseplate)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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Leakage underneath the baseplate [ Time Frame: two weeks ]
- Peristomal skin condition [ Time Frame: Two weeks ]Measured by the Ostomy Skin Tool
- Security [ Time Frame: Two weeks ]The participants feeling of security when wearing the product, measured on a 5-point scale
- Handling [ Time Frame: Two weeks ]The participants ease of handling the products, measured on a 5-point scale
- Comfort [ Time Frame: Two weeks ]The participants feeling of comfort when wearing the product, measured on a 5-point scale
- Adverse events [ Time Frame: Two weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT01448629
|Principal Investigator:||Carol Katte, MD||Ashford and St. Peters Hospital|