IleostomyNCT02594085
An Exploratory Study Investigating Adhesive Reaction to Output
A study testing Patch 1, Patch 2 and Patch 3 in people with Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The objective is to investigate the impact that faecal output has on 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?
- Patch 1, Patch 2 and Patch 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 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 3 months
- Have intact skin on the area used in the evaluation
- Has an ileostomy with a diameter (≤) 35mm
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 area
- Convex user
- Participate in other interventional clinical investigations
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to investigate the impact that faecal output has on adhesives.
- Conditions
- Ileostomy
- Being tested
- Patch 1, Patch 2, Patch 3, Patch 4, patch 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch 1Other
Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Patch 2Other
Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Patch 3Other
Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip
Patch 4Other
Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
patch 5Other
Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Patch 6Other
Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
| Study group | Role | What they receive |
|---|---|---|
| Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6 Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6 |
| Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6 |
| Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6 |
| Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2 Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6 |
| Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2 Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6 |
| Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remaining adherent area of the adhesive
The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startOct 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
- Randomised
- Intervention model
- Crossover
- 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
- Birte P Jakobsen, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594085
- Sponsor's protocol ID
- CP261
- Status last verified
- Jan 2016
- First submitted
- 30 Oct 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
- An Exploratory Study Investigating Adhesive Reaction to Output
- ClinicalTrials.gov ID
- NCT02594085
- Acronym / sponsor ID
- CP261
- Conditions
- Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 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 objective is to investigate the impact that faecal output has on adhesives.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: patch 5, Other: Patch 6The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6 |
| Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: patch 5, Other: Patch 6The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 |
| Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: patch 5, Other: Patch 6The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 |
| Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: patch 5, Other: Patch 6The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2 |
| Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: patch 5, Other: Patch 6The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2 |
| Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: patch 5, Other: Patch 6The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 3 months
- Have intact skin on the area used in the evaluation
- Has an ileostomy with a diameter (≤) 35mm
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 area
- Convex user
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 |
|---|---|---|
| Patch 1Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip | Other | Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6, Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4, Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6, Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4, Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2, Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 |
| Patch 2Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip | Other | Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6, Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4, Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6, Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4, Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2, Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 |
| Patch 3Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip | Other | Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6, Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4, Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6, Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4, Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2, Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 |
| Patch 4Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip | Other | Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6, Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4, Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6, Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4, Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2, Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 |
| patch 5Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip | Other | Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6, Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4, Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6, Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4, Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2, Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 |
| Patch 6Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip | Other | Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6, Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4, Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6, Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4, Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2, Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 |
Primary outcome
Remaining adherent area of the adhesive
Time frame: 8 hours
The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling.
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.
Related trials for Ileostomy
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruitingPhase 2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
Crohn's Disease
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative Colitis, Ileal Pouch
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
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.
Birte P Jakobsen, MD principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patch 1, Patch 2 and Patch 3 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 5 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 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 adherent area of the adhesive (time frame: 8 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.