Colostomy StomaNCT01918085
Human Skin Test Model in Colostomists
A study testing Hydrocolloid strip and Strata strip in people with Colostomy Stoma, run by Coloplast A/S.
Trial summary
The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colostomy Stoma
- What is being tested?
- Hydrocolloid strip and Strata strip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to May 2012
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have given written informed consent.
- Be in the age of 45 to 75 years of age both extremes included.
- Have had a colostomy for at least 1 year.
- Has a colostomy with a diameter up to (≤) 40 mm.
- Have mental capacity to understand the study guidelines and questionnaires.
- Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
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- Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
- Have a BMI between 20-30 kg/m2.
- Are willing to comply with investigation procedures.
Who cannot join
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Received radio- and/or chemotherapy within the last two months.
- Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.
- on peristomal skin (injections and oral treatment are accepted).
- Have dermatological problems.
- Participating in other clinical studies or have previously participated in this test.
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- Be a daily user of a convex base-plate.
- Are pregnant or breastfeeding.
- Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
About this study
Official title: Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists
The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.
- Conditions
- Colostomy Stoma
- Being tested
- Hydrocolloid strip, Strata strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocolloid stripOther
An adhesive strip made of hydrocolloid adhesive
Strata stripOther
An adhesive strip made of the Strata adhesive
| Study group | Role | What they receive |
|---|---|---|
| Peristomal skin | Other | The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin Receives: Other: Hydrocolloid strip; Other: Strata strip |
| Pre-stripped abdominal skin | Other | The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin Receives: Other: Hydrocolloid strip; Other: Strata strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peel Force
The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees.
The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tonny Karlsmark, MD, Principal investigator, Bispebjerg Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918085
- Sponsor's protocol ID
- CP228
- Status last verified
- Jan 2014
- First submitted
- 6 Aug 2013
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists
- ClinicalTrials.gov ID
- NCT01918085
- Acronym / sponsor ID
- CP228
- Conditions
- Colostomy Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peristomal skin | Other | Other: Hydrocolloid strip, Other: Strata stripThe peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin |
| Pre-stripped abdominal skin | Other | Other: Hydrocolloid strip, Other: Strata stripThe peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have given written informed consent.
- Be in the age of 45 to 75 years of age both extremes included.
- Have had a colostomy for at least 1 year.
- Has a colostomy with a diameter up to (≤) 40 mm.
- Have mental capacity to understand the study guidelines and questionnaires.
Key exclusion criteria (9 listed)
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Received radio- and/or chemotherapy within the last two months.
- Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.
- on peristomal skin (injections and oral treatment are accepted).
- Have dermatological problems.
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 |
|---|---|---|
| Hydrocolloid stripAn adhesive strip made of hydrocolloid adhesive | Other | Peristomal skin, Pre-stripped abdominal skin |
| Strata stripAn adhesive strip made of the Strata adhesive | Other | Peristomal skin, Pre-stripped abdominal skin |
Primary outcome
Peel Force
Time frame: 1 hour
The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees. The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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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Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
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Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
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Effects of Stoma Education on Patients
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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.
Tonny Karlsmark, MD principal investigator
Bispebjerg Hospital, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocolloid strip and Strata strip in people with Colostomy Stoma, run by Coloplast A/S.
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 9 inclusion and 9 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 12 Mar 2014). 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?
Peel Force (time frame: 1 hour). 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 12 Mar 2014.