HealthyNCT01245413
Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin
A study testing SenSura and Athena in people with Healthy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
Aim The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma. The present investigation aims at testing how well the new Athena base plate adhere to perspiring skin both with and without mechanical exposure (cycling) since… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SenSura and Athena
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Dec 2010
- 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A: Men without a stoma in the age of 50-70 years Group B: Men with a stoma
- To be included in the investigation, the subjects in Group A must comply with the following selection criteria:
- Have signed informed consent and letter of attorney
- Be a man in the age of 50-70 years
- Is capable of understanding the experiment
- Have a BMI (body mass index) between 20-30 kg/m2
Show all 16Show fewer
- Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
- Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
- To be included in the investigation, the subjects in Group B must comply with the following selection criteria:
- Have signed informed consent and letter of attorney
- Be a man of at least 18 years of age
- Have a colostomy with a max width of 45 mm and have had the colostomy for at least 3 months
- Is capable of understanding the experiment
- Have a BMI between 20-30 kg/m2
- Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
- Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
Who cannot join
- Subjects who comply with the following criteria must be excluded from the investigation:
- Have dermatological problems
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Have elevated cholesterol levels, elevated blood pressure, diabetes or any form of cardiovascular disease.
- Currently receiving or have within the last 3 weeks received local treatment with steroids (ointment or creme) on back or stomach*
- Group A may not have a stoma
- Group B may not use convex base plates * Radio- and chemotherapy can lead to changes in the skin and intestine. It is known that steroid can lead to fragile skin which can affect application and removal of the adhesive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Randomized Study With a New Base Plate Versus SenSura Base Plate on Perspiring Skin
Aim
The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma.
Read more
The present investigation aims at testing how well the new Athena base plate adhere to perspiring skin both with and without mechanical exposure (cycling) since the ability to adhere under normal daily activity is an important quality for Coloplast products.
Success criteria:
The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura.
Design:
Two groups of men, one group with a colostomy and one group without a colostomy, are included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate intensity and with Athena and SenSura base plates applied on the back and stomach. The adhesion of the base plates are tested before and after the physical activities.
Population:
The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate intensity on an exercise bike.
The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat custom cut base plate, a closed bag size midi or maxi with the intended use of collecting faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy product with a closed bag. SenSura is CE-marked and launched on the market.
Read the detailed description
The aim of the Athena project is to develop an ostomy product, for people with a colostomy, with better comfort than other normal ostomy products. This has been attempted through development of a soft and flexible base plate that follows the contours of the body.
It is the aim of Coloplast to gain knowledge about whether the Athena base plate can adhere to peristomal skin to the same degree as the SenSura base plate in situations of perspiration both with and without mechanical exposure.
Primary endpoint Calculation of the area of the base plate that has detached from the skin. The area is based on a visual evaluation of Athena and SenSura adhesives measured on the skin of the stomach after 1 hour of cycling at moderate intensity.
Secondary endpoint(s)
- Registration of the weight of the adhesive after physical activity on the bike and after 1 hour in a warm room.
- Evaluation of the effects on the skin measured as number of skin cells on the adhesive after use.
- Loss of liquid.
- Peel test (tractive force) of the adhesive on the skin of the stomach (mechanical exposure and perspiration).
- Peel test (tractive force) of the adhesive on the skin of the back (perspiration without the mechanical exposure).
- Calculation of the area that has detached from the skin based on a visual evaluation of the adhesives on the skin of the back (perspiration without mechanical exposure).
- Mechanical evaluation of the area of the adhesive that no longer adhere to the skin on both the stomach and on the back.
Safety endpoint(s)
- Test of health (is evaluated by the responsible physician and cardiologist).
- Test of fitness (fitness rating).
- Unexpected clinical occurrence (adverse events, AE) / Serious unexpected clinical occurrence (serious adverse events, SAE).
Criteria of success The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura.
Design of the clinical study Study design The investigation is designed as a randomized control study with 2 groups: A and B. Group A includes 15 healthy men in the age of 50-70 years who have volunteered. Group B includes 15 men with a colostomy who have volunteered. All persons included should have a healthy cardiovascular system (see below) allowing them to accomplish one hour of cycling at moderate intensity. Both screening and test will take place at the Physicians Test Centre (Lægernes Test Center), Skodsborg Strandvej 215 A, 2942 Skodsborg, Denmark.
40 participants will be invited for screening. Those who are evaluated as suitable will be invited to proceed in the investigation. If more than 15 men without a stoma or more than 15 men with a stoma are evaluated as suitable for the test then the additional persons will be invited to register on a waiting list and they will be informed about participation in the investigation if needed. If less than 15 men without a stoma or 15 men with a stoma are evaluate as suitable then the investigation will proceed with the persons available. There will be no further recruitment of additional subjects after the screening.
The Clinical Protocol is signed by the responsible investigator at the Physicians Test Centre before the test will take place. The responsible investigator and other physicians who will act as investigators will receive thorough information about the investigation. Before recruitment of subjects the investigators will be trained in how to inform the subjects about the investigation and how to fill in the CRF (Case Report Form)(inclusive training in how to perform the different tests of adhesive qualities).
On the day of screening the subjects will be examined by an investigator with regard to health and fitness. The examination will take place at the Physicians Test Centre. The examination will also include an interview regarding life style. The cardiological data will be evaluated by a cardiologist. Persons will be invited for another one or two test days if the investigator finds that the person is able to do one hour of cycling at moderate intensity without risk and otherwise comply with the inclusion criteria.
- Conditions
- Healthy
- Being tested
- SenSura, Athena
- Keywords
- Stoma, adhesive, warm, moist, cycling, men, peel-value, healthy men 50-70 years old, men with colostoma, above 18 years
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSuraDevice
Also called ostomy appliance
Adhesive to stoma bag
AthenaDevice
Also called ostomy appliance
Adhesive to stoma bag
| Study group | Role | What they receive |
|---|---|---|
| SenSura Adhesive (device) | Active comparator | Sensura is a commercially available adhesive, that is designed to collect output from a stoma. Receives: Device: SenSura |
| Athena adhesive | Experimental | Athena = new test adhesive. The Athena baseplate is intended for collecting output from a stoma. Receives: Device: Athena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Inspection of Baseplate Loosening
The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm^2
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 posted22 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionDec 2010
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 HealthyStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lægernes Test Center A/S
- Responsible party
- Sponsor
- Investigators
- Claus Hyldahl, MD, Principal investigator, Lægehuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245413
- Sponsor's protocol ID
- CP213OC
- Status last verified
- Nov 2012
- First submitted
- 16 Nov 2010
- Last updated
- 1 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Randomized Study With a New Base Plate Versus SenSura Base Plate on Perspiring Skin
- ClinicalTrials.gov ID
- NCT01245413
- Acronym / sponsor ID
- CP213OC
- Conditions
- Healthy
- Keywords
- Stoma, adhesive, warm, moist, cycling, men, peel-value, healthy men 50-70 years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Collaborators
- Lægernes Test Center A/S
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 1 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim
The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma.
The present investigation aims at testing how well the new Athena base plate adhere to perspiring skin both with and without mechanical exposure (cycling) since the ability to adhere under normal daily activity is an important quality for Coloplast products.
Success criteria:
The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura.
Design:
Two groups of men, one group with a colostomy and one group without a colostomy, are included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate intensity and with Athena and SenSura base plates applied on the back and stomach. The adhesion of the base plates are tested before and after the physical activities.
Population:
The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate intensity on an exercise bike.
The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat custom cut base plate, a closed bag size midi or maxi with the intended use of collecting faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy product with a closed bag. SenSura is CE-marked and launched on the market.
Detailed description
The aim of the Athena project is to develop an ostomy product, for people with a colostomy, with better comfort than other normal ostomy products. This has been attempted through development of a soft and flexible base plate that follows the contours of the body.
It is the aim of Coloplast to gain knowledge about whether the Athena base plate can adhere to peristomal skin to the same degree as the SenSura base plate in situations of perspiration both with and without mechanical exposure.
Primary endpoint Calculation of the area of the base plate that has detached from the skin. The area is based on a visual evaluation of Athena and SenSura adhesives measured on the skin of the stomach after 1 hour of cycling at moderate intensity.
Secondary endpoint(s)
- Registration of the weight of the adhesive after physical activity on the bike and after 1 hour in a warm room.
- Evaluation of the effects on the skin measured as number of skin cells on the adhesive after use.
- Loss of liquid.
- Peel test (tractive force) of the adhesive on the skin of the stomach (mechanical exposure and perspiration).
- Peel test (tractive force) of the adhesive on the skin of the back (perspiration without the mechanical exposure).
- Calculation of the area that has detached from the skin based on a visual evaluation of the adhesives on the skin of the back (perspiration without mechanical exposure).
- Mechanical evaluation of the area of the adhesive that no longer adhere to the skin on both the stomach and on the back.
Safety endpoint(s)
- Test of health (is evaluated by the responsible physician and cardiologist).
- Test of fitness (fitness rating).
- Unexpected clinical occurrence (adverse events, AE) / Serious unexpected clinical occurrence (serious adverse events, SAE).
Criteria of success The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura.
Design of the clinical study Study design The investigation is designed as a randomized control study with 2 groups: A and B. Group A includes 15 healthy men in the age of 50-70 years who have volunteered. Group B includes 15 men with a colostomy who have volunteered. All persons included should have a healthy cardiovascular system (see below) allowing them to accomplish one hour of cycling at moderate intensity. Both screening and test will take place at the Physicians Test Centre (Lægernes Test Center), Skodsborg Strandvej 215 A, 2942 Skodsborg, Denmark.
40 participants will be invited for screening. Those who are evaluated as suitable will be invited to proceed in the investigation. If more than 15 men without a stoma or more than 15 men with a stoma are evaluated as suitable for the test then the additional persons will be invited to register on a waiting list and they will be informed about participation in the investigation if needed. If less than 15 men without a stoma or 15 men with a stoma are evaluate as suitable then the investigation will proceed with the persons available. There will be no further recruitment of additional subjects after the screening.
The Clinical Protocol is signed by the responsible investigator at the Physicians Test Centre before the test will take place. The responsible investigator and other physicians who will act as investigators will receive thorough information about the investigation. Before recruitment of subjects the investigators will be trained in how to inform the subjects about the investigation and how to fill in the CRF (Case Report Form)(inclusive training in how to perform the different tests of adhesive qualities).
On the day of screening the subjects will be examined by an investigator with regard to health and fitness. The examination will take place at the Physicians Test Centre. The examination will also include an interview regarding life style. The cardiological data will be evaluated by a cardiologist. Persons will be invited for another one or two test days if the investigator finds that the person is able to do one hour of cycling at moderate intensity without risk and otherwise comply with the inclusion criteria.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SenSura Adhesive (device) | Active comparator | Device: SenSuraSensura is a commercially available adhesive, that is designed to collect output from a stoma. |
| Athena adhesive | Experimental | Device: AthenaAthena = new test adhesive. The Athena baseplate is intended for collecting output from a stoma. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Group A: Men without a stoma in the age of 50-70 years Group B: Men with a stoma
- To be included in the investigation, the subjects in Group A must comply with the following selection criteria:
- Have signed informed consent and letter of attorney
- Be a man in the age of 50-70 years
- Is capable of understanding the experiment
Key exclusion criteria (7 listed)
- Subjects who comply with the following criteria must be excluded from the investigation:
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 |
|---|---|---|
| SenSuraAlso: ostomy applianceAdhesive to stoma bag | Device | SenSura Adhesive (device) |
| AthenaAlso: ostomy applianceAdhesive to stoma bag | Device | Athena adhesive |
Primary outcome
Visual Inspection of Baseplate Loosening
Time frame: 1 hour
The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm^2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Claus Hyldahl, MD principal investigator
Lægehuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenSura and Athena in people with Healthy, 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 16 inclusion and 7 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 Jan 2013. 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 1 Jan 2013). 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?
Visual Inspection of Baseplate Loosening (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 1 Jan 2013.