Ileostomy - StomaNCT03289013
Assessement of the Peal Force Needed to Peel New Adhesives From the Skin
A study testing Standard adhesive 1, Standard adhesive 2 and LT-2 in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
This study investigates the adhesion of new adhesives to the skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Standard adhesive 1, Standard adhesive 2 and LT-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Sep 2017to 21 Dec 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
- Healthy volunteers accepted
- 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 intact skin on the area used in the investigation
Who cannot join
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Have dermatological problems in the abdominal area (assessed by investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
This study investigates the adhesion of new adhesives to the skin.
- Conditions
- Ileostomy - Stoma
- Being tested
- Standard adhesive 1, Standard adhesive 2, LT-2, LT-21, LT-25
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard adhesive 1Other
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
Standard adhesive 2Other
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
LT-2Other
Newly developed adhesive
LT-21Other
Newly developed adhesive
LT-25Other
Newly developed adhesive
33-20Other
Newly developed adhesive
| Study group | Role | What they receive |
|---|---|---|
| Testing of new adhesive strips | Experimental | Each subject will test six adhesive strips on pre-stripped skin.
1. Standard adhesive 1
2. Standard adhesive 2
3. LT-2
4. LT-21
5. LT-25
6. 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits. Receives: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: LT-2; Other: LT-21; Other: LT-25; Other: 33-20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swelling of the adhesive
- Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start11 Sep 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lene Feldskov, Principal investigator, Head of preclinical department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289013
- Sponsor's protocol ID
- CP267_02
- Status last verified
- Jan 2018
- First submitted
- 18 Sep 2017
- Last updated
- 1 Feb 2018
- 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 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
- ClinicalTrials.gov ID
- NCT03289013
- Acronym / sponsor ID
- CP267_02
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 20 Sep 2017 (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 adhesion of new adhesives to the skin.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing of new adhesive strips | Experimental | Other: Standard adhesive 1, Other: Standard adhesive 2, Other: LT-2, Other: LT-21, Other: LT-25, Other: 33-20Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have intact skin on the area used in the investigation
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 months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Have dermatological problems in the abdominal 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 |
|---|---|---|
| Standard adhesive 1This strip consists of a standard hydrocolloid adhesive found in ostomy devices | Other | Testing of new adhesive strips |
| Standard adhesive 2This strip consists of a standard hydrocolloid adhesive found in ostomy devices | Other | Testing of new adhesive strips |
| LT-2Newly developed adhesive | Other | Testing of new adhesive strips |
| LT-21Newly developed adhesive | Other | Testing of new adhesive strips |
| LT-25Newly developed adhesive | Other | Testing of new adhesive strips |
| 33-20Newly developed adhesive | Other | Testing of new adhesive strips |
Primary outcome
Swelling of the adhesive
Time frame: 21 days
1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)
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 2018.
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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 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 Standard adhesive 1, Standard adhesive 2 and LT-2 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 3 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 1 Feb 2018. 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?
Swelling of the adhesive (time frame: 21 days). 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 2018.