Stoma Site LeakageNCT04544566
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
A study testing Test product A, Test product B and Comparator in people with Stoma Site Leakage, run by Coloplast A/S at 1 site in Denmark.
Trial summary
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Site Leakage
- What is being tested?
- Test product A, Test product B and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jul 2020to 21 Aug 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 written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than ½ year
- Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
- Willing to change baseplate every second day or less frequent
- Willing to avoid using Concave baseplate during the study.
- Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.
Who cannot join
- Currently receiving or have within the past 2 months received radio-and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
- Is pregnant or breastfeeding
- Having dermatological problems in the peristomal area (assessed by investigator)
Trial locations and contacts
1 site in 1 country.
About this study
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
Read the detailed description
The test products are non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
- Conditions
- Stoma Site Leakage
- Being tested
- Test product A, Test product B, Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product ADevice
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product BDevice
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
ComparatorDevice
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
| Study group | Role | What they receive |
|---|---|---|
| Test product A new adhesive material | Experimental | The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. Receives: Device: Test product A; Device: Test product B; Device: Comparator |
| Test product B new adhesion material | Experimental | The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. Receives: Device: Test product A; Device: Test product B; Device: Comparator |
| Comparator | Active comparator | The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation. Receives: Device: Test product A; Device: Test product B; Device: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Adherent Area Measured by Photo of Used Tape
The adherent area (cm2) measured per baseplate change after use shows how effectively the ostomy tape adheres to the skin. After removal of the ostomy tape, a photo of the tape was taken. The adherent area was measured from the photo and an image analysing program.
Measured: Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation
Secondary outcomes (7)
Erythema Measured After Each Treatment Period by Spectrophotometric Method
A change in the surface skin colour is known to be related to a change in the blood flow. This can be measured non-invasively with a spectrophotometric instrument (Derma-spectrophotometer, Cortex Technology A/S, Hadsund) where redness of the skin is measured. The measurement of erythema is based on an active color detecting chip. Illumination is provided by two high intensity white LEDs. The spectrophotometer accommodates the color sensor, filters, optics and light source. Light is provided by two high intensity with LEDs and a unique feature is the guiding light, which illuminates the target during the positioning of the device. The LEDs illuminates the target area and the skin color measurement is performed. The measurements performed with the spectrophotometric instrument do not have units. But the measures are used for the estimation of the level of the redness (hemoglobin) in the skin. The higher the value, the more pigment in the skin.
Measured: The measurements were carried out after 7-9 days of treatment with the test tape
Erythema Measured After Tape Removal by Photos
A change in the surface skin colour is known to be related to a change in the blood flow. This can be measured non-invasively with a spectrophotometric instrument (Derma-spectrophotometer, Cortex Technology A/S, Hadsund) where both the redness and the colour of the skin are measured. Furthermore, visual assessments of photos have been used in several exploratory clinical investigations by Coloplast A/S to explore how adhesives affect the skin. The visual assessment is conducted by trained personnel and is a valuable tool for assessing newly developed adhesives and their impact on skin in the early development phases.
Measured: The measurements were carried out after 7-9 days of treatment with the test tape
Feeling of Security
Subjects will be asked how they rate feeling of security ("How was the feeling of security?) on a five point scale, when wearing the tape; 1. Very Poor, 2. Poor, 3. Acceptable, 4. Good, 5. Very Good.
Measured: The evaluation was carried out after 7-9 days of treatment with the test tape
Adhesion of Tape
Subjects will be asked how they perceive the immediate adhesion to the skin ("how was the immediate adhesion to the skin?) and rate adhesion on a five-point scale: 1. Very poor, 2. Poor, 3. Acceptable, 4. Good, 5. Very good.
Measured: The evaluation was carried out after 7-9 days of treatment with the test tape
Comfort
Subjects will be asked how they perceived the comfort of the tape ("How comfortable was the tape to wear?") and rate comfort on a 5-pont scale; 1. very discomfortable, 2. Discomfortable, 3. Acceptable, 4. Comfortable, 5. Very comfortable.
Measured: The evaluation was carried out after 7-9 days of treatment with the test tape
Skin Issues in the Area Covered by the Tape
Subjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no).
Measured: The evaluation was carried out after 7-9 days of treatment with the test tape
Adverse Events
All Adverse Events are captured and documented throughout the study.
Measured: 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start7 Jul 2020
- Primary completion21 Aug 2020
- Study completion21 Aug 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 Stoma Site 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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, Bispebjerg hospital, Dermato-Venerologisk afdeling.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544566
- Sponsor's protocol ID
- CP319
- Status last verified
- Apr 2021
- First submitted
- 26 Jun 2020
- Last updated
- 6 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
- ClinicalTrials.gov ID
- NCT04544566
- Acronym / sponsor ID
- CP319
- Conditions
- Stoma Site Leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Posted 6 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
Detailed description
The test products are non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product A new adhesive material | Experimental | Device: Test product A, Device: Test product B, Device: ComparatorThe adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. |
| Test product B new adhesion material | Experimental | Device: Test product A, Device: Test product B, Device: ComparatorThe adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. |
| Comparator | Active comparator | Device: Test product A, Device: Test product B, Device: ComparatorThe comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than ½ year
- Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
- Willing to change baseplate every second day or less frequent
Key exclusion criteria (4 listed)
- Currently receiving or have within the past 2 months received radio-and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
- Is pregnant or breastfeeding
- Having dermatological problems in the peristomal area (assessed by investigator)
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 |
|---|---|---|
| Test product Aone new adhesive material which is applied to the baseplate and the subjects peristomal skin | Device | Comparator, Test product A new adhesive material, Test product B new adhesion material |
| Test product Bone new adhesive material which is applied to the baseplate and the subjects peristomal skin | Device | Comparator, Test product A new adhesive material, Test product B new adhesion material |
| ComparatorAlready CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin | Device | Comparator, Test product A new adhesive material, Test product B new adhesion material |
Primary outcome
Mean Adherent Area Measured by Photo of Used Tape
Time frame: Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation
The adherent area (cm2) measured per baseplate change after use shows how effectively the ostomy tape adheres to the skin. After removal of the ostomy tape, a photo of the tape was taken. The adherent area was measured from the photo and an image analysing program.
7 secondary outcomes
Erythema Measured After Each Treatment Period by Spectrophotometric Method
Time frame: The measurements were carried out after 7-9 days of treatment with the test tape
Erythema Measured After Tape Removal by Photos
Time frame: The measurements were carried out after 7-9 days of treatment with the test tape
Feeling of Security
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Adhesion of Tape
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Comfort
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Skin Issues in the Area Covered by the Tape
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Adverse Events
Time frame: 27 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Bispebjerg hospital, Dermato-Venerologisk afdeling.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product A, Test product B and Comparator in people with Stoma Site Leakage, 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 7 inclusion and 4 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 6 May 2021. 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 6 May 2021). 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?
Mean Adherent Area Measured by Photo of Used Tape (time frame: Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation). 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 6 May 2021.