Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01243294
First received: August 9, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.


Condition Intervention Phase
Colostomy
Device: SS
Device: SenSura
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Leakage (Percent of All Base Plates With Leakage) [ Time Frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day ] [ Designated as safety issue: No ]
    Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: During the investigation ~ 24 days per subject ] [ Designated as safety issue: Yes ]
    Safety is evaluated by adverse events occuring continues while the subjects are testing the devices

  • Security (Subjects Own Assessment) [ Time Frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product ] [ Designated as safety issue: No ]

    Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.

    Unit of measure is: Percentage of participants answering 'very good'


  • Handling at Appliance (Subjects Own Assessment) [ Time Frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product ] [ Designated as safety issue: No ]

    Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.

    Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.

    Unit of measure is: Percentage of participants answering 'very easy' and 'easy'


  • Comfort (Subjects Own Assessment) [ Time Frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product ] [ Designated as safety issue: No ]

    Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.

    Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.

    Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'


  • Wear Time (Registered by Subject When Applying and Removing a Product) [ Time Frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day ] [ Designated as safety issue: No ]
    Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.


Enrollment: 56
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SenSura
CE marked and launched (The letters "CE" do not represent any specific words, though may have initially stood for "Communauté Européenne" ("European Community") or "Conformité Européenne" ("European Conformity"). By affixing the CE marking to a product, the manufacturer declares that it meets EU safety and health and environmental requirements.
Device: SS
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
Other Names:
  • SenSura
  • New ostomy appliance
Device: SenSura
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
Other Names:
  • SenSura
  • New ostomy appliance
Active Comparator: New ostomy appliance (SS)
SS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names.
Device: SS
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
Other Names:
  • SenSura
  • New ostomy appliance
Device: SenSura
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
Other Names:
  • SenSura
  • New ostomy appliance

Detailed Description:

Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems.

To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics.

The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.

The study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home.

50 healthy subjects with a colostomy will be included in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have given written informed consent
  • Be at least 18 years of age and have full legal capacity
  • Be able to handle the bags themselves (application, removal)
  • Have a colostomy with a diameter less than 45 mm
  • Have had a colostomy for at least 3 months
  • Currently use a 1-piece flat ostomy appliance with closed bag
  • is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
  • Use minimum 1 product per day
  • Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
  • Have the mental capacity to understand the study and questionnaires

Exclusion Criteria:

  • Use irrigation during the study (flush the stoma with water).
  • Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
  • Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
  • Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
  • Are pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243294

Locations
Denmark
Coloplast A/S
Humlebæk, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Pia Nordmand, MSc Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01243294     History of Changes
Other Study ID Numbers: CP209OC
Study First Received: August 9, 2010
Results First Received: February 17, 2011
Last Updated: October 4, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

ClinicalTrials.gov processed this record on August 28, 2014