Ileostomy - StomaNCT03423134
Investigating the Performance of a New Adhesive Strip
A study testing New adhesive strip in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
This study investigates the performance of a new adhesive Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- New adhesive strip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jan 2018to 20 Feb 2018
- 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
Who may be able to join
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than one year
- Have intact skin on the area used in the evaluation
- Has a stoma with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
Who cannot join
- Currently receiving or have within the past 2 month 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.
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
- Actively participating in other interventional clinical investigations or have previously participated in this investigation.
- 5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put
This study investigates the performance of a new adhesive
- Conditions
- Ileostomy - Stoma
- Being tested
- New adhesive strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New adhesive stripOther
This is a strip made of a newly developed adhesive
| Study group | Role | What they receive |
|---|---|---|
| Test of new adhesive strip | Experimental | A new adhesive strip will be tested in this investigation Receives: Other: New adhesive strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
trans epidermal water loss
The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start25 Jan 2018
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lene F Nielsen, Principal investigator, Head of the pre-clinical department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423134
- Sponsor's protocol ID
- CP265_19
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2018
- Last updated
- 1 Feb 2019
- Results posted
- No
- 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 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put
- ClinicalTrials.gov ID
- NCT03423134
- Acronym / sponsor ID
- CP265_19
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 6 Feb 2018 (actual)
- 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.
This study investigates the performance of a new adhesive
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test of new adhesive strip | Experimental | Other: New adhesive stripA new adhesive strip will be tested in this investigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than one year
- Have intact skin on the area used in the evaluation
- Has a stoma with a diameter up to (≤) 35 mm
Key exclusion criteria (6 listed)
- Currently receiving or have within the past 2 month 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.
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
- Actively participating in other interventional clinical investigations or have previously participated in this 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 |
|---|---|---|
| New adhesive stripThis is a strip made of a newly developed adhesive | Other | Test of new adhesive strip |
Primary outcome
trans epidermal water loss
Time frame: 24 hours
The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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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.
Lene F Nielsen principal investigator
Head of the pre-clinical department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New adhesive strip in people with Ileostomy - Stoma, 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 6 inclusion and 6 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 1 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
trans epidermal water loss (time frame: 24 hours). 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 1 Feb 2019.