Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin
Condition: Healthy
Study type: Interventional

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 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.
    

Intervention name(s): SenSura; Athena
Intervention type(s): Device; Device
Intervention description(s): Adhesive to stoma bag; Adhesive to stoma bag
Other intervention name(s): ostomy appliance; ostomy appliance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Stoma; adhesive; warm; moist; cycling; men; peel-value; healthy men 50-70 years old; men with colostoma, above 18 years