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

NCT01245413 | Completed Results

• 1 other identifier: CP213OC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Stoma; adhesive; warm; moist; cycling; men; peel-value; healthy men 50-70 years old; men with colostoma, above 18 years

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SenSura Adhesive (device)

ACTIVE COMPARATOR

Sensura is a commercially available adhesive, that is designed to collect output from a stoma.

Device: SenSura

Athena adhesive

EXPERIMENTAL

Athena = new test adhesive. The Athena baseplate is intended for collecting output from a stoma.

Device: Athena

Interventions

SenSura DEVICE

Adhesive to stoma bag

Also known as: ostomy appliance

SenSura Adhesive (device)

Athena DEVICE

Adhesive to stoma bag

Also known as: ostomy appliance

Athena adhesive

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead
• Lægernes Test Center A/S: collaborator

Study Sites (1)

Lægernes Test Center A/S

Skodsborg, 2942, Denmark

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Claus Hyldahl
• Organization: Lægehuset, Skodsborg Strandvej 125A, 2942 Skodsborg, Denmark

hyldahl@info.dk

4545801331

Study Officials

• Claus Hyldahl, MD

  Lægehuset

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 22, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 1, 2013
• Results First Posted: January 1, 2013

Record last verified: 2012-11

Locations

DK (1)