LeakageNCT01448629
Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
A study testing River in people with Leakage and Skin Condition, run by Coloplast A/S.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leakage, Skin Condition
- What is being tested?
- River
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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
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.
Read more
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.
Read the detailed description
See brief summary
- Conditions
- Leakage, Skin Condition
- Being tested
- Standard Care, River
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareDevice
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.
RiverDevice
River is a new developed product with Coloplast as manufacturer
| Study group | Role | What they receive |
|---|---|---|
| River | Experimental | Not described Receives: Device: River |
| Standard Care | Active comparator | Standard Care can have several manufacture and brand names. Standard Care is defined af the participants currently used stoma care product. Receives: Device: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage underneath the baseplate
Measured: two weeks
Secondary outcomes (5)
Peristomal skin condition
Measured by the Ostomy Skin Tool
Measured: Two weeks
Security
The participants feeling of security when wearing the product, measured on a 5-point scale
Measured: Two weeks
Handling
The participants ease of handling the products, measured on a 5-point scale
Measured: Two weeks
Comfort
The participants feeling of comfort when wearing the product, measured on a 5-point scale
Measured: Two weeks
Adverse events
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: The study was withdrawn because of problems found with the baseplate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeakageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Katte, MD, Principal investigator, Ashford and St. Peters Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448629
- Sponsor's protocol ID
- CP214OC
- Status last verified
- Feb 2012
- First submitted
- 18 Aug 2011
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01448629
- Acronym / sponsor ID
- CP214OC
- Conditions
- Leakage, Skin Condition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn because of problems found with the baseplate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| River | Experimental | Device: River |
| Standard Care | Active comparator | Device: Standard CareStandard Care can have several manufacture and brand names. Standard Care is defined af the participants currently used stoma care product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareParticipants 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. | Device | Standard Care |
| RiverRiver is a new developed product with Coloplast as manufacturer | Device | River |
Primary outcome
Leakage underneath the baseplate
Time frame: two weeks
5 secondary outcomes
Peristomal skin condition
Time frame: Two weeks
Security
Time frame: Two weeks
Handling
Time frame: Two weeks
Comfort
Time frame: Two weeks
Adverse events
Time frame: Two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
Related trials for Leakage
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
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Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
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RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
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Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Katte, MD principal investigator
Ashford and St. Peters Hospital
Questions about this trial
What is this clinical trial studying?
A study testing River in people with Leakage and Skin Condition, run by Coloplast A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leakage underneath the baseplate (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.