Ileostomy - StomaNCT03044275
The Influence of Output on Skin Covered by Adhesive With Topfilm
A study testing New adhesive strip and Standard adhesive strip in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm. 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 and Standard adhesive strip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jan 2017to 10 May 2017
- 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 an ileostomy for more than one year
- Have intact skin on the area used in the evaluation
- Has an ileostomy 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)
- Participating in other interventional clinical investigations or have previously participated in this evaluation -
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.
- Conditions
- Ileostomy - Stoma
- Being tested
- New adhesive strip, Standard 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 newly developed adhesive strip that in the future might be part of an ostomy device
Standard adhesive stripOther
This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device
| Study group | Role | What they receive |
|---|---|---|
| Cohort 8 | Experimental | This is a sub-study testing the effect of real output on the skin applied under two adhesive strips.
New adhesive strip Standard adhesive strip Receives: Other: New adhesive strip; Other: Standard adhesive strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans epidermal water loss
the condition of the skin (trans epidermal water loss) is measured after removing the adhesive from the skin
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start16 Jan 2017
- Primary completion10 May 2017
- Study completion10 May 2017
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lene Feldskov, M. Sci, Principal investigator, Head of preclinical department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044275
- Sponsor's protocol ID
- CP265_08
- Status last verified
- May 2017
- First submitted
- 31 Jan 2017
- Last updated
- 31 May 2017
- Results posted
- No
- 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 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Output on Skin Covered by Adhesive With Topfilm
- ClinicalTrials.gov ID
- NCT03044275
- Acronym / sponsor ID
- CP265_08
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 7 Feb 2017 (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.
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 8 | Experimental | Other: New adhesive strip, Other: Standard adhesive stripThis is a sub-study testing the effect of real output on the skin applied under two adhesive strips. New adhesive strip Standard adhesive strip |
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 an ileostomy for more than one year
- Have intact skin on the area used in the evaluation
- Has an ileostomy with a diameter up to (≤) 35 mm
Key exclusion criteria (5 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)
- Participating in other interventional clinical investigations or have previously participated in this evaluation -
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 newly developed adhesive strip that in the future might be part of an ostomy device | Other | Cohort 8 |
| Standard adhesive stripThis is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device | Other | Cohort 8 |
Primary outcome
Trans epidermal water loss
Time frame: 6 hours
the condition of the skin (trans epidermal water loss) is measured after removing the adhesive from the skin
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 31 May 2017.
- Individual participant dataSharing planned: No
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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 Feldskov, M. Sci principal investigator
Head of preclinical 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 and Standard 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 5 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 31 May 2017. 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: 6 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 31 May 2017.