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Completed

NCT Number: NCT01243294

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

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

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Key information

Conditions

Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SS

Device

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

SenSura

Device

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: New ostomy appliance

Primary outcomes

  1. 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

    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 outcomes

  1. Adverse Events

    Time frame: During the investigation ~ 24 days per subject

    Safety is evaluated by adverse events occuring continues while the subjects are testing the devices

  2. 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

    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'

  3. 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

    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'

  4. 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

    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'

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2010
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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