Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Controlled Randomized Study With a New Base Plate Versus SenSura Base Plate on Perspiring Skin

Conditions
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Healthy

Intervention / Treatment
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* Device: SenSura
* Device: Athena


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group A: Men without a stoma in the age of 50-70 years Group B: Men with a stoma Inclusion criteria: 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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SenSura Adhesive (device)<br>Sensura is a commercially available adhesive, that is designed to collect output from a stoma. | Device: SenSura<br>* Adhesive to stoma bag<br>* Other names: ostomy appliance;|
| Experimental: Athena adhesive<br>Athena = new test adhesive. The Athena baseplate is intended for collecting output from a stoma. | Device: Athena<br>* Adhesive to stoma bag<br>* Other names: ostomy appliance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stoma, adhesive, warm, moist, cycling, men, peel-value, healthy men 50-70 years old, men with colostoma, above 18 years