Peristomal Skin ComplicationCP288NCT04101318
Investigation of a New Stoma Product for People With a Stoma
A study testing Non-Conformité Européene marked product and Conformité Européene marked competitor products in people with Peristomal Skin Complication, run by Coloplast A/S at 1 site in Norway.
Trial summary
The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peristomal Skin Complication
- What is being tested?
- Non-Conformité Européene marked product and Conformité Européene marked competitor products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteNorway
- Study dates
- 22 Jan 2020to 17 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Has given informed consent to participate by signing the informed consent signature form.
- Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale)
- Currently using a flat product
- Be at least 18 years of age and have full legal capacity
- Have had their stoma for at least three months (90 days)
- Can use a product with a max cut size of 40 mm
Show all 16Show fewer
- Has experienced leakage* under the baseplate at least three times within the last 14 days. *leakage defined as output seeping under the baseplate (Appendix 6 - Classification of leakage)
- Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below
- Has experienced symptoms of skin complications (itching, burning, pain) within the last fourteen days
- Has experienced red skin in the inner circle (within three cm from stoma edge) within the last fourteen days
- Has skin complication (assessed by Principal Investigator, or delegate) in the inner circle (within three cm from stoma edge) of the peristomal area
- Is able to handle the electronic diary (questionnaire/ photo) themselves.
- Is able to handle (apply, remove, cut etc.) the product themselves
- Is willing to not use barrier film or barrier cream during the investigation
- Is willing and suitable (determined by Principal Investigator, or delegate) to use a flat custom cut one-piece open or a two-piece open product during the investigation.
- Is willing to change the product (1pc) or baseplate (2pc) at least every fourth days.
Who cannot join
- Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
- low doses chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.
- Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray.
- Low dose systemic steroid treatment (e.g. inhalation) assessed by the Principal Investigator are allowed.
- Other systemic steroid treatment (e.g. injection, or tablet) are not allowed.
- Is breastfeeding
Show all 9Show fewer
- Is pregnant (based on pregnancy test -urine)
- Has known hypersensitivity towards any of the products used in the investigation
- -
Trial locations and contacts
1 site in 1 country.
About this study
The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.
Read the detailed description
Enrolled participant with an ileostomy or colostomy with liquid output were randomized to test either the non-Conformité Européene marked investigational product or one of the five comparators Conformité Européene marked products first and then will be crossed over to receive the opposite intervention.
The participant will first be included in an information and inclusion visit (V0) and after signing all consent forms will complete three test visits (V1, V2, and V3). Each participant will be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a maximum of 90 days.
The study is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation with two test periods. The study was conducted in four different countries (UK, Germany, Italy, and Norway) with a total of six sites participating.
The study is now complete.
- Conditions
- Peristomal Skin Complication
- Being tested
- Non-Conformité Européene marked product, Conformité Européene marked competitor products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Conformité Européene marked productDevice
New Baseplate is not named at this point
Conformité Européene marked competitor productsDevice
The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.
| Study group | Role | What they receive |
|---|---|---|
| The non-Conformité Européene marked product, a Conformité Européene marked product | Experimental | Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days. Receives: Device: Non-Conformité Européene marked product; Device: Conformité Européene marked competitor products |
| A Conformité Européene marked product, then the non-Conformité Européene marked product | Experimental | Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days. Receives: Device: Non-Conformité Européene marked product; Device: Conformité Européene marked competitor products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Max Itching Within a Week at Steady State
Participant were asked to rate their itching around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible peristomal skin itch. The primary outcome measure was done on the Intended to Treat population. Steady state period of the treatment period began after three weeks of product use.
Measured: Within a week at steady state
Secondary outcomes (17)
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment
Participants were asked how often they had experienced itchy skin around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: "None of the time", "A little of the time", Some of the time", A lot of the time", and "All of the time". The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as "how many percentages are the answers from one category out of a total of 100% (all the answers)?".
Measured: past 14 days by end of treatment
Max Pain Within a Week at Steady State
Participant were asked to rate their pain around the ostomy on a scale of 0-10 with 0= no pain ad 10= worst possible pain. Steady state period of the treatment period began after three weeks of product use.
Measured: Within one week at steady state
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment
Participants were asked how often they had experienced pain around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: "None of the time", "A little of the time", Some of the time", A lot of the time", and "All of the time". The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as "how many percentages are the answers from one category out of a total of 100% (all the answers)?".
Measured: past 14 days by end of treatment
Max Burning Within a Week at Steady State
Participant were asked to rate burning around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible burning sensation. Steady state period of the treatment period began after three weeks of product use.
Measured: Within one week at steady state
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment
Participants were asked how often they had experienced a burning sensation around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: "None of the time", "A little of the time", Some of the time", A lot of the time", and "All of the time". The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as "how many percentages are the answers from one category out of a total of 100% (all the answers)?".
Measured: past 14 days by end of treatment
Bleeding Around the Ostomy at Each Baseplate Change at Steady State
Participant were asked if they had experienced bleeding around the ostomy within 1 week. Steady state period of the treatment period began after three weeks of product use.
Measured: Within one week at steady state
Weeping Around the Ostomy at Each Baseplate Change at Steady State
Participant were asked if they had experienced weeping around the ostomy within 1 week. Steady state period of the treatment period begins after three weeks of product use.
Measured: Within one week at steady state
Ulcers Around the Ostomy at Each Baseplate Change at Steady State
Participant were asked if they had experienced ulcers around the ostomy within 1 week. Steady state period of the treatment period began after three weeks of product use.
Measured: Within one week at steady state
Max Overall Physical Discomfort Within a Week Per Baseplate Change at Steady State
Participant were asked to rate their overall physical discomfort around the ostomy on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use.
Measured: Within one week at steady state
Max Overall Ability to Move Around Within a Week Per Baseplate Change at Steady State
Participant were asked to rate their overall ability to move around on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use.
Measured: Within one week at steady state
Max Overall Ability to Stick the Stoma Bag Adhesive to the Skin Within a Week Per Baseplate Change at Steady State
Participant were asked to rate the overall ability to stick the stoma bag adhesive to their skin since last change of product on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use.
Measured: Within one week at steady state
Discoloration Area (cm^2) Per Baseplate Change at Steady State
Participant were asked to take photos of their peristomal skin at each baseplate change. The discoloration area of the peristomal skin was determined using an algorithm. The algorithm estimated the area of the discolored skin (divided into three different zones). Steady state period of the treatment period began after three weeks of product use.
Measured: 3 weeks
Intensity of Discolorated Area Scored Per Baseplate Change at Steady State After Three Weeks of Product Use
Photos of the peristomal skin was taken at each baseplate change. The intensity was determined with an overlay to the artificial intelligence algorithm. The overlay divided the area into ten different intensity intervals: "Intensity interval 1"=0-10 …., "Intensity interval 10"=91-100% redness. The score was then calculated as follows: 1*(Interval 1 measurement)..+ 10*(Interval 10 measurement). Thus, if the area was within the first interval (0-10% redness) it was multiplied with 1 or within Interval 10 it was multiplied with 10, resulting in a intensity score for the total area. If there is no discoloration the score is 0, and there is no theoretical maximum. A large score equals a high intensity on the skin. In the description of the endpoint (appendix. 1 in CIP), it was to be determined in the inner and outer zone per baseplate change at steady state. However, the algorithm only estimated a total intensity score; thus, the intensity will not be reported per inner and outer zone.
Measured: 3 weeks
Total Discoloration, Erosion, and Tissue Overgrowth (DET) Score by End of Treatment at Steady State
Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. They determined the discoloration, erosion, and tissue overgrowth domain by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected by each domain. Each three domains contributes to the calculation of the total Discoloration, Erosion and Tissue overgrowth score (DET) going from a scale of 0 to 15 ("Normal skin" (DET=0), "Mild" (DET=2- 3), "Moderate" (DET=4- 6), and "Severe" (7-15)).
Steady state period of the treatment period began after three weeks of product use.
Measured: 3 weeks
Discoloration Item Score by End of Treatment at Steady State
Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Discoloration is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15. The discoloration domain was scored by area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and the scores were added together for a total discoloration score (with the max total score being 5). The area is assessed first and if this is 0 then the score for discoloration is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more discolored skin.
Steady state period of the treatment period began after three weeks of product use
Measured: 3 weeks
Erosion Item Score by End of Treatment at Steady State
Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Erosion is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15.The erosion domain was determined by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and then adding the scores together for a total score (with the max total score being 5). The area is assessed first and if this is 0 then the score for erosion is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more eroded skin.
Steady state period of the treatment period began after three weeks of product use.
Measured: 3 weeks
Tissue Overgrowth Item Score by End of Treatment at Steady State
Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Tissue overgrowth is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15. The Tissue Overgrowth domain was assessed by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and then adding the scores together for a total score (with the max total score being 5). The area is assessed first and if this is 0 then the score for tissue overgrowth is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more tissue overgrowth.
Steady state period of the treatment period began after three weeks of product use.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start22 Jan 2020
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peristomal Skin ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nazarena Mazzarro, MD, Study director, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101318
- Sponsor's protocol ID
- CP288
- Acronym
- CP288
- Status last verified
- Nov 2022
- First submitted
- 6 Sep 2019
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a New Stoma Product for People With a Stoma
- ClinicalTrials.gov ID
- NCT04101318
- Acronym / sponsor ID
- CP288 / CP288
- Conditions
- Peristomal Skin Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.
Detailed description
Enrolled participant with an ileostomy or colostomy with liquid output were randomized to test either the non-Conformité Européene marked investigational product or one of the five comparators Conformité Européene marked products first and then will be crossed over to receive the opposite intervention.
The participant will first be included in an information and inclusion visit (V0) and after signing all consent forms will complete three test visits (V1, V2, and V3). Each participant will be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a maximum of 90 days.
The study is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation with two test periods. The study was conducted in four different countries (UK, Germany, Italy, and Norway) with a total of six sites participating.
The study is now complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The non-Conformité Européene marked product, a Conformité Européene marked product | Experimental | Device: Non-Conformité Européene marked product, Device: Conformité Européene marked competitor productsParticipants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days. |
| A Conformité Européene marked product, then the non-Conformité Européene marked product | Experimental | Device: Non-Conformité Européene marked product, Device: Conformité Européene marked competitor productsParticipants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has given informed consent to participate by signing the informed consent signature form.
- Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale)
- Currently using a flat product
- Be at least 18 years of age and have full legal capacity
- Have had their stoma for at least three months (90 days)
Key exclusion criteria (9 listed)
- Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
- Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray.
- Is breastfeeding
- Is pregnant (based on pregnancy test -urine)
- Has known hypersensitivity towards any of the products used in the investigation
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 |
|---|---|---|
| Non-Conformité Européene marked productNew Baseplate is not named at this point | Device | A Conformité Européene marked product, then the non-Conformité Européene marked product, The non-Conformité Européene marked product, a Conformité Européene marked product |
| Conformité Européene marked competitor productsThe Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years. | Device | A Conformité Européene marked product, then the non-Conformité Européene marked product, The non-Conformité Européene marked product, a Conformité Européene marked product |
Primary outcome
Max Itching Within a Week at Steady State
Time frame: Within a week at steady state
Participant were asked to rate their itching around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible peristomal skin itch. The primary outcome measure was done on the Intended to Treat population. Steady state period of the treatment period began after three weeks of product use.
17 secondary outcomes
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment
Time frame: past 14 days by end of treatment
Max Pain Within a Week at Steady State
Time frame: Within one week at steady state
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment
Time frame: past 14 days by end of treatment
Max Burning Within a Week at Steady State
Time frame: Within one week at steady state
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment
Time frame: past 14 days by end of treatment
Bleeding Around the Ostomy at Each Baseplate Change at Steady State
Time frame: Within one week at steady state
Weeping Around the Ostomy at Each Baseplate Change at Steady State
Time frame: Within one week at steady state
Ulcers Around the Ostomy at Each Baseplate Change at Steady State
Time frame: Within one week at steady state
Max Overall Physical Discomfort Within a Week Per Baseplate Change at Steady State
Time frame: Within one week at steady state
Max Overall Ability to Move Around Within a Week Per Baseplate Change at Steady State
Time frame: Within one week at steady state
Max Overall Ability to Stick the Stoma Bag Adhesive to the Skin Within a Week Per Baseplate Change at Steady State
Time frame: Within one week at steady state
Discoloration Area (cm^2) Per Baseplate Change at Steady State
Time frame: 3 weeks
Intensity of Discolorated Area Scored Per Baseplate Change at Steady State After Three Weeks of Product Use
Time frame: 3 weeks
Total Discoloration, Erosion, and Tissue Overgrowth (DET) Score by End of Treatment at Steady State
Time frame: 3 weeks
Discoloration Item Score by End of Treatment at Steady State
Time frame: 3 weeks
Erosion Item Score by End of Treatment at Steady State
Time frame: 3 weeks
Tissue Overgrowth Item Score by End of Treatment at Steady State
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peristomal Skin Complication
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
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.
Nazarena Mazzarro, MD study director
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Conformité Européene marked product and Conformité Européene marked competitor products in people with Peristomal Skin Complication, run by Coloplast A/S at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Max Itching Within a Week at Steady State (time frame: Within a week at steady state). 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 21 Sep 2023.