Colostomy StomaNCT01995357

The Influence of Baseplate Adhesive on the Degree of Leakage

A study testing Coloplast Test A, Coloplast Test B and Standard product in people with Colostomy Stoma and Ileostomy Stoma, run by Coloplast A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colostomy Stoma, Ileostomy Stoma
What is being tested?: Coloplast Test A, Coloplast Test B and Standard product
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteDenmark
Study dates: Oct 2013to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 and signed letter of authority
Be at least 18 years of age and have full legal capacity
Have had their ileostomy/colostomy for at least 3 months
Have a stoma with a diameter between 15 and 36 mm
Be able to handle the products themselves
Be able to use a custom cut product

Show all 12Show fewer

Normally experience faeces under the base plate at least 3 times during 2 weeks
Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
Be willing to test the test products without using paste and/or ring
Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
Be suitable for participation in the investigation
Be able to present a negative result of a pregnancy test - for women of childbearing age

Who cannot join

Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
Are pregnant or breastfeeding
Are participating in other interventional clinical investigations or have previously participated in this investigation
Use irrigation during the investigation (flush the intestines with water)
Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
Have a loop stoma
Have known hypersensitivity towards any of the test products (including adhesive remover)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Coloplast A/S
Humlebæk, 3050

Other trials in Denmark

About this study

Official title: The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Conditions: Colostomy Stoma, Ileostomy Stoma
Being tested: Coloplast Test A, Coloplast Test B, Standard product

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coloplast Test ADevice
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test BDevice
Coloplast Test B is a newly developed ostomy appliance.
Standard productDevice
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.

Study groups in NCT01995357
Study group	Role	What they receive
First Coloplast Teast A; then Coloplast Test B	Experimental	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Standard product
First Coloplast Test A; Then Standard product	Experimental	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Standard product
First Coloplast Test B; Then Colopast Test A	Experimental	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Standard product
First Coloplast Test B; Then Standard product	Experimental	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Standard product
First Standard product; Then Coloplast Test A	Experimental	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Standard product
First Standard Product, Then Coloplast test B	Experimental	There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Standard product

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of Leakage
The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).
Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
Measured: 10 (- 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Dec 2013

First posted26 Nov 2013 (estimated)
Study startOct 2013
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colostomy 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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01995357
Sponsor's protocol ID: CP244
Status last verified: Feb 2015
First submitted: 21 Nov 2013
Last updated: 3 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
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RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
Active, not recruiting
Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
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All Colostomy Stoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy
ClinicalTrials.gov ID: NCT01995357
Acronym / sponsor ID: CP244
Conditions: Colostomy Stoma, Ileostomy Stoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 26 Nov 2013 (estimated)
Results: Posted 3 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
First Coloplast Teast A; then Coloplast Test B	Experimental	Device: Coloplast Test A, Device: Coloplast Test B, Device: Standard productThere are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
First Coloplast Test A; Then Standard product	Experimental	Device: Coloplast Test A, Device: Coloplast Test B, Device: Standard productThere are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
First Coloplast Test B; Then Colopast Test A	Experimental	Device: Coloplast Test A, Device: Coloplast Test B, Device: Standard productThere are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
First Coloplast Test B; Then Standard product	Experimental	Device: Coloplast Test A, Device: Coloplast Test B, Device: Standard productThere are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
First Standard product; Then Coloplast Test A	Experimental	Device: Coloplast Test A, Device: Coloplast Test B, Device: Standard productThere are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
First Standard Product, Then Coloplast test B	Experimental	Device: Coloplast Test A, Device: Coloplast Test B, Device: Standard productThere are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Have given written informed consent and signed letter of authority
Be at least 18 years of age and have full legal capacity
Have had their ileostomy/colostomy for at least 3 months
Have a stoma with a diameter between 15 and 36 mm
Be able to handle the products themselves

Key exclusion criteria (8 listed)

Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
Are pregnant or breastfeeding
Are participating in other interventional clinical investigations or have previously participated in this investigation
Use irrigation during the investigation (flush the intestines with water)

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
Coloplast Test AColoplast Test A is a newly developed ostomy appliance	Device	First Coloplast Teast A; then Coloplast Test B, First Coloplast Test A; Then Standard product, First Coloplast Test B; Then Colopast Test A, First Coloplast Test B; Then Standard product, First Standard Product, Then Coloplast test B, First Standard product; Then Coloplast Test A
Coloplast Test BColoplast Test B is a newly developed ostomy appliance.	Device	First Coloplast Teast A; then Coloplast Test B, First Coloplast Test A; Then Standard product, First Coloplast Test B; Then Colopast Test A, First Coloplast Test B; Then Standard product, First Standard Product, Then Coloplast test B, First Standard product; Then Coloplast Test A
Standard productStandard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.	Device	First Coloplast Teast A; then Coloplast Test B, First Coloplast Test A; Then Standard product, First Coloplast Test B; Then Colopast Test A, First Coloplast Test B; Then Standard product, First Standard Product, Then Coloplast test B, First Standard product; Then Coloplast Test A

Primary outcome

Degree of Leakage
Time frame: 10 (- 2 days)
The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.

Results and safety

Results posted to the registry on 3 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First Coloplast Teast A; Then Coloplast Test B	4	4
First Coloplast Test A; Then Standard Product	3	3
First Coloplast Test B; Then Colopast Test A	4	4
First Coloplast Test B; Then Standard Product	3	3
First Standard Product; Then Coloplast Test A	4	4
First Standard Product, Then Coloplast Test B	4	4

Primary outcome: Degree of Leakage

Time frame: 10 (- 2 days). Mean (Standard Deviation). Unit: units on a scale

Measure	Colostomy ,Test A n = 16	Colostomy, Training + Test A n = 16	Colostomy, Test B n = 16	Colostomy, Training + Test B n = 15	Colostomy, Standard Care (SenSura Mio) n = 13	Colostomy, Standard Care (SenSura) n = 3	Ileostomy, Test A n = 6	Ileostomy, Training + Test A n = 5	Ileostomy, Test B n = 6	Ileostomy, Training + Test B n = 5	Ileostomy, Standard Care (SenSura) n = 6
Value	3.6 (5.0)	2.4 (4.2)	5.5 (5.5)	4.8 (5.1)	3.7 (6.5)	3.3 (3.2)	9.1 (5.2)	9.7 (5.7)	11.5 (5.3)	12.9 (5.6)	8.5 (5.1)

Adverse events

Time frame: Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test A + Training Test A	0 of 22 (0%)	8 of 22 (36.4%)	Not reported
Test B + Training Test B	0 of 22 (0%)	9 of 22 (40.9%)	Not reported
Standard Care	0 of 22 (0%)	3 of 22 (13.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colostomy Stoma

RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
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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.

Birte P Jakobsen, MD principal investigator

Coloplast A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Coloplast Test A, Coloplast Test B and Standard product in people with Colostomy Stoma and 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 12 inclusion and 8 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 3 Feb 2015. 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?

Yes. Results are posted in the registry (first posted 3 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Degree of Leakage (time frame: 10 (- 2 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01995357.

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 3 Feb 2015.