Peristomal Skin ComplicationCP338NCT04868617
A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
A study testing ATTRACT-I in people with Peristomal Skin Complication, run by Coloplast A/S at 1 site in Denmark.
Trial summary
This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. 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?
- ATTRACT-I
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 13 Feb 2022
- 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 written consent to participate by signing the Informed Consent Signature Form
- Is at least 18 years of age and have full legal capacity
- Has an ileostomy or colostomy with consistent liquid fecal output (6-7 Bristol scale.
- Is currently using a SenSura® Mio flat product with open bag.
- Has had the ostomy for at least 90 days.
- Can use an ostomy product with a max cut size of 45 mm (1-piece) or 38 mm (2-piece).
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- Has experienced leakage** under the baseplate at least three times within the last fourteen days.
- Leakage defined as output/seeping under the baseplate (see appendix 7)
- Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last fourteen days. **
- Proper training of the PI and nurses in how to ask the subject about these symptoms is essential.
- Is able to handle the electronic diary (questionnaire/photo) themselves. If needed, a trained spouse or caretaker is allowed to assist.
- Is able to handle (apply, remove, cut, etc.) the product themselves.
- Understands that any barrier products (film, cream, spray, wipes etc.) are not permissible during the investigation, and is willing to not use these accessories during the investigation.
- Is willing and suitable (determined by the Principal Investigator or designee) to use a flat custom cut one-piece open or two-piece open product during the investigation.
- Is willing to change the product (1-piece) or baseplate (2-piece) 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 radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
- Is currently receiving or have within the past 30 days 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 investigator are allowed.
- Other systemic steroid treatment (e.g., injection or tablet) are not allowed.
- Is breastfeeding.
- Is pregnant based on urine pregnancy test.
- Has known hypersensitivity towards any of the products used in the investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ATTRACT-I: A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days in total for the entire investigation, thus approximately 70 days. The subjects will test the non-CE marked test product and the comparator product in randomized order.
Read the detailed description
People with intestinal stomas have, despite development of better stoma products, problems with leakage induced peristomal skin complications which influence quality of life negatively. In fact, the primary cause of peristomal skin complication development is due to leakage of ostomy effluents under the adhesive barrier. Some of the common clinical signs of peristomal skin complications include pain, itching, burning, discoloration, bleeding, and wounds . To overcome this, Coloplast A/S has developed a new baseplate which is comprised of a protective layer.
This investigation is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation, with two test periods. In total 82 subjects will be included and randomised, and each subject will have at least three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days; thus approximately 70 days. The subjects will test the non-CE marked investigational product and the comparator product in a randomised order.
Before the test periods, the subjects are invited for a screening visit (V0). Subjects will be consented prior to any study procedures. Once consented, during their participation, the subjects will complete three study visits (V1, V2 and V3). The visits can be at the Principal Investigators clinic or in the subject's home. In rare cases (i.e. global pandemic), visits can be done remotely via video conference. In addition, the Principal Investigator, or designee, will call the subjects four times during the course of the investigation to inquire if the subject has had any issues or concerns.
During the test visits the subject will complete a quality of life questionnaire and discuss/record any adverse events or device deficiencies. The subject will also be asked about the use and handling of the product, and their preference.
At every baseplate change the subjects will be asked to take photos of their stoma/peristomal skin and the backside (adhesive side) of the used product. The photos will be taken with a smartphone using the Coloplast Clinical Trial App. The subject will also be asked to complete a questionnaire about their peristomal skin condition.
Coloplast will provide both the investigational product and the comparator product for all subjects.
If a subject experiences a problem with the investigational product during the investigation, he/she should contact the investigator for advice. Subjects that cannot complete a test period with the test product may choose to use their own product (i.e., SenSura® Mio) for the remainder of the test period. However, this must be documented by the Principal Investigator.
The duration of the test periods (35 -1/+3 days) and number of visits should be adequate to assess data on the skin condition of the subjects. The investigational products are tested for 35 -1/+3 days in each study period to ensure that the skin will have time to adjust to new conditions, reach a steady state, and for the subjects to test the product for an adequate number of days to give a thorough evaluation of the products.
To account for a possible carry-over effect, the steady state period of the treatment period begins after two weeks of product use. It is anticipated that the skin will have adapted to the new product after two weeks.
- Conditions
- Peristomal Skin Complication
- Being tested
- ATTRACT-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTRACT-IDevice
The aim of this investigation is to evaluate the performance and safety of an ostomy baseplate with a novel skin protection technology and its ability to reduce peristomal skin complications compared to SenSura® Mio. The subject will be randomized to either test product or comparator at enrollment. The subject will wear the test product for approximately 35 days and then cross-over to the comparator (or vice-versa) for approximately 35 days. At each baseplate change, the subject will answer questions about their skin, and take pictures of their stoma and used baseplate. They will also answer quality of life questionnaires at each study visit.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | The non-CE marked test product is a stoma product based on the flat SenSura® Mio 1-piece (1-pc) and the flat 2-piece with mechanical coupling (2-pc MC) product that includes a novel skin protective layer in the baseplate. Receives: Device: ATTRACT-I |
| SenSura® Mio Comparator - Standard of Care | Active comparator | The following comparator products will be used in this investigation:
* SenSura® Mio 1-piece (1-pc) flat, Midi bag with normal outlet and
* SenSura® Mio 2-piece with mechanical coupling (2-pc MC) flat, Maxi or Midi bag with normal outlet Receives: Device: ATTRACT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3)
The peristomal skin condition measured by the Decision Tree Score on baseplate level at steady state (scale from 0-3). Higher score means worse outcome
Measured: after 5 weeks
Secondary outcomes (1)
Health-related Quality of Life (Scale 0-30)
A health-related quality of life measured by the DLQI score evaluated at the end of each test period (scale from 0-30, the higher the score, the worse the QoL for the participant)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Sep 2021
- Primary completion13 Feb 2022
- Study completion13 Feb 2022
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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tonny Karlsmark, MD, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868617
- Sponsor's protocol ID
- CP338
- Acronym
- CP338
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2021
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATTRACT-I: A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
- ClinicalTrials.gov ID
- NCT04868617
- Acronym / sponsor ID
- CP338 / CP338
- Conditions
- Peristomal Skin Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 13 Feb 2022 (actual)
- Study completion
- 13 Feb 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days in total for the entire investigation, thus approximately 70 days. The subjects will test the non-CE marked test product and the comparator product in randomized order.
Detailed description
People with intestinal stomas have, despite development of better stoma products, problems with leakage induced peristomal skin complications which influence quality of life negatively. In fact, the primary cause of peristomal skin complication development is due to leakage of ostomy effluents under the adhesive barrier. Some of the common clinical signs of peristomal skin complications include pain, itching, burning, discoloration, bleeding, and wounds . To overcome this, Coloplast A/S has developed a new baseplate which is comprised of a protective layer.
This investigation is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation, with two test periods. In total 82 subjects will be included and randomised, and each subject will have at least three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days; thus approximately 70 days. The subjects will test the non-CE marked investigational product and the comparator product in a randomised order.
Before the test periods, the subjects are invited for a screening visit (V0). Subjects will be consented prior to any study procedures. Once consented, during their participation, the subjects will complete three study visits (V1, V2 and V3). The visits can be at the Principal Investigators clinic or in the subject's home. In rare cases (i.e. global pandemic), visits can be done remotely via video conference. In addition, the Principal Investigator, or designee, will call the subjects four times during the course of the investigation to inquire if the subject has had any issues or concerns.
During the test visits the subject will complete a quality of life questionnaire and discuss/record any adverse events or device deficiencies. The subject will also be asked about the use and handling of the product, and their preference.
At every baseplate change the subjects will be asked to take photos of their stoma/peristomal skin and the backside (adhesive side) of the used product. The photos will be taken with a smartphone using the Coloplast Clinical Trial App. The subject will also be asked to complete a questionnaire about their peristomal skin condition.
Coloplast will provide both the investigational product and the comparator product for all subjects.
If a subject experiences a problem with the investigational product during the investigation, he/she should contact the investigator for advice. Subjects that cannot complete a test period with the test product may choose to use their own product (i.e., SenSura® Mio) for the remainder of the test period. However, this must be documented by the Principal Investigator.
The duration of the test periods (35 -1/+3 days) and number of visits should be adequate to assess data on the skin condition of the subjects. The investigational products are tested for 35 -1/+3 days in each study period to ensure that the skin will have time to adjust to new conditions, reach a steady state, and for the subjects to test the product for an adequate number of days to give a thorough evaluation of the products.
To account for a possible carry-over effect, the steady state period of the treatment period begins after two weeks of product use. It is anticipated that the skin will have adapted to the new product after two weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Device: ATTRACT-IThe non-CE marked test product is a stoma product based on the flat SenSura® Mio 1-piece (1-pc) and the flat 2-piece with mechanical coupling (2-pc MC) product that includes a novel skin protective layer in the baseplate. |
| SenSura® Mio Comparator - Standard of Care | Active comparator | Device: ATTRACT-IThe following comparator products will be used in this investigation: * SenSura® Mio 1-piece (1-pc) flat, Midi bag with normal outlet and * SenSura® Mio 2-piece with mechanical coupling (2-pc MC) flat, Maxi or Midi bag with normal outlet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Has given written consent to participate by signing the Informed Consent Signature Form
- Is at least 18 years of age and have full legal capacity
- Has an ileostomy or colostomy with consistent liquid fecal output (6-7 Bristol scale.
- Is currently using a SenSura® Mio flat product with open bag.
- Has had the ostomy for at least 90 days.
Key exclusion criteria (8 listed)
- Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
- Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.
- Is breastfeeding.
- Is pregnant based on urine pregnancy test.
- 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 |
|---|---|---|
| ATTRACT-IThe aim of this investigation is to evaluate the performance and safety of an ostomy baseplate with a novel skin protection technology and its ability to reduce peristomal skin complications compared to SenSura® Mio. The subject will be randomized to either test product or comparator at enrollment. The subject will wear the test product for approximately 35 days and then cross-over to the comparator (or vice-versa) for approximately 35 days. At each baseplate change, the subject will answer questions about their skin, and take pictures of their stoma and used baseplate. They will also answer quality of life questionnaires at each study visit. | Device | SenSura® Mio Comparator - Standard of Care, Test Product |
Primary outcome
The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3)
Time frame: after 5 weeks
The peristomal skin condition measured by the Decision Tree Score on baseplate level at steady state (scale from 0-3). Higher score means worse outcome
1 secondary outcome
Health-related Quality of Life (Scale 0-30)
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- 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.
Tonny Karlsmark, MD principal investigator
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 ATTRACT-I in people with Peristomal Skin Complication, run by Coloplast A/S at 1 site in Denmark.
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 15 inclusion and 8 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 30 Apr 2025. 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 Denmark. 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 30 Apr 2025). 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?
The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3) (time frame: after 5 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 30 Apr 2025.