IleostomyNCT02610907
A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put
A study testing Buffer, Own output and simulated output in people with Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy
- What is being tested?
- Buffer, Own output and simulated output
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to Jan 2016
- 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 (subjects own) and simulated output have on the adhesion of adhesives.
- Conditions
- Ileostomy
- Being tested
- Buffer, Own output, simulated output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BufferOther
The sleeve contains phosphate buffered saline buffer
Own outputOther
The sleeve contains the subject own ileal effluent
simulated outputOther
The sleeve contains simulated output
| Study group | Role | What they receive |
|---|---|---|
| Cohort 01a | Experimental | This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions:
Buffer Own output Simulated output (digestive enzymes)
All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously. Receives: Other: Buffer; Other: Own output; Other: simulated output |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remaining adhesive area of adhesive
The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleostomyStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lene F Nielsen, MSc, Principal investigator, R&D Principal Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610907
- Sponsor's protocol ID
- CP265_01
- Status last verified
- Jan 2016
- First submitted
- 16 Nov 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put
- ClinicalTrials.gov ID
- NCT02610907
- Acronym / sponsor ID
- CP265_01
- Conditions
- Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Nov 2015 (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 (subjects own) and simulated output have on the adhesion of adhesives.
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 01a | Experimental | Other: Buffer, Other: Own output, Other: simulated outputThis is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously. |
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 |
|---|---|---|
| BufferThe sleeve contains phosphate buffered saline buffer | Other | Cohort 01a |
| Own outputThe sleeve contains the subject own ileal effluent | Other | Cohort 01a |
| simulated outputThe sleeve contains simulated output | Other | Cohort 01a |
Primary outcome
Remaining adhesive area of adhesive
Time frame: 30 hours
The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.
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 20 Jan 2016.
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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, MSc principal investigator
R&D Principal Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buffer, Own output and simulated output in people with Ileostomy, 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 20 Jan 2016. 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?
Remaining adhesive area of adhesive (time frame: 30 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 20 Jan 2016.