Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
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.
|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|
- Leakage underneath the baseplate [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||May 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448629
|Principal Investigator:||Carol Katte, MD||Ashford and St. Peters Hospital|