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

This study has been completed.
Sponsor:
Collaborator:
Lægernes Test Center A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01245413
First received: November 16, 2010
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Device: SenSura
Device: Athena

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Controlled Randomized Study With a New Base Plate Versus SenSura Base Plate on Perspiring Skin

Resource links provided by NLM:

MedlinePlus related topics: Ostomy Sweat
U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Visual Inspection of Baseplate Loosening [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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


Enrollment: 32
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SenSura Adhesive (device)
Sensura is a commercially available adhesive, that is designed to collect output from a stoma.
 Device: SenSura
Adhesive to stoma bag
Other Name: ostomy appliance
Experimental: Athena adhesive
Athena = new test adhesive. The Athena baseplate is intended for collecting output from a stoma.
 Device: Athena
Adhesive to stoma bag
Other Name: ostomy appliance

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245413

Locations
Denmark
Lægernes Test Center A/S
Skodsborg, Denmark, 2942
Sponsors and Collaborators
Coloplast A/S
Lægernes Test Center A/S
Investigators
Principal Investigator: Claus Hyldahl, MD Lægehuset
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01245413     History of Changes
Other Study ID Numbers: CP213OC
Study First Received: November 16, 2010
Results First Received: January 9, 2012
Last Updated: November 29, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Coloplast A/S:
Stoma
adhesive
warm
moist
cycling
 men
peel-value
healthy men 50-70 years old
men with colostoma, above 18 years

ClinicalTrials.gov processed this record on May 23, 2013