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

October 4, 2011 updated by: Coloplast A/S

Cross-over, Open Label 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Humlebæk, Denmark, 3050
        • Coloplast A/S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • 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:
  • New ostomy appliance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
During the investigation ~ 24 days per subject
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'
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 (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'
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 (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'
After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
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.
After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coloplast A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pia Nordmand, MSc, Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP209OC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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