Ileostomy - StomaNCT03439176
Investigating the Adhesion of New Adhesive to the Skin
A study testing Standard adhesive 1, Standard adhesive 2 and PL4 in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The adhesion of the new adhesive strips is investigated on healthy volunteers 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 PL4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2018to 30 Jun 2020
- 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
The adhesion of the new adhesive strips is investigated on healthy volunteers
Read the detailed description
Inclusion visit:
- Introduction to the study
- Inclusion in study
- Baseline information is obtained
- Instruct subject to pre-strip of abdominal skin
Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):
- Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
- Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
- Adhesive strips are weighted and applied
- Potential shower/bicycle exercise (max 60 minutes)
- Adhesive strips are removed at pre-defined timeslots (peel force measured)
- Discomfort when strip was peeled of is evaluated by subject (VAS)
- Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
- Acclimatization ½
- Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
- Adhesive strips are weighed
- Photo of adhesive strips
The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.
- Conditions
- Ileostomy - Stoma
- Being tested
- Standard adhesive 1, Standard adhesive 2, PL4, PL16-L
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard adhesive 1Other
This strip contains a standard hydrocolloid adhesive found in ostomy devices
Standard adhesive 2Other
This strip contains a standard hydrocolloid adhesive found in ostomy devices
PL4Other
This strip contains a new adhesive
PL16-LOther
This strip contains a new adhesive
| Study group | Role | What they receive |
|---|---|---|
| Test of new adhesive strips | Experimental | The subjects will test adhesives strips made of 4 different adhesives:
Standard adhesive 1 Standard adhesive 2 PL4 PL16-L Receives: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: PL4; Other: PL16-L |
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 the weight of the strip before and after use)
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 posted20 Feb 2018
- Study start15 Jan 2018
- Primary completion15 Feb 2018
- Study completion30 Jun 2020 (estimated)
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
- NCT03439176
- Sponsor's protocol ID
- CP267_3_5
- Status last verified
- Jan 2020
- First submitted
- 31 Jan 2018
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. 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
- NCT03439176
- Acronym / sponsor ID
- CP267_3_5
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 20 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.
The adhesion of the new adhesive strips is investigated on healthy volunteers
Detailed description
Inclusion visit:
- Introduction to the study
- Inclusion in study
- Baseline information is obtained
- Instruct subject to pre-strip of abdominal skin
Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):
- Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
- Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
- Adhesive strips are weighted and applied
- Potential shower/bicycle exercise (max 60 minutes)
- Adhesive strips are removed at pre-defined timeslots (peel force measured)
- Discomfort when strip was peeled of is evaluated by subject (VAS)
- Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
- Acclimatization ½
- Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
- Adhesive strips are weighed
- Photo of adhesive strips
The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.
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 strips | Experimental | Other: Standard adhesive 1, Other: Standard adhesive 2, Other: PL4, Other: PL16-LThe subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L |
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 contains a standard hydrocolloid adhesive found in ostomy devices | Other | Test of new adhesive strips |
| Standard adhesive 2This strip contains a standard hydrocolloid adhesive found in ostomy devices | Other | Test of new adhesive strips |
| PL4This strip contains a new adhesive | Other | Test of new adhesive strips |
| PL16-LThis strip contains a new adhesive | Other | Test of new adhesive strips |
Primary outcome
Swelling of the adhesive
Time frame: 24 hours
Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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 Standard adhesive 1, Standard adhesive 2 and PL4 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. 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?
Results are not available in the source record.
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: 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 27 Jan 2020.