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Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799239
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : December 5, 2013
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Device: Test product Device: SenSura Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arm Intervention/treatment
Experimental: First Test product; then SenSura

The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.

After cross-over the subject test SenSura which is CE-marked and commerical available.

Device: Test product
The test product consists of an adhesive with a new top film

Device: SenSura
SenSura is the CE-marked and commercially available comparator product

Active Comparator: First SenSura, Then Test product

The subject in this arm first test SenSura which is CE-marked and commerical available.

After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.

Device: Test product
The test product consists of an adhesive with a new top film

Device: SenSura
SenSura is the CE-marked and commercially available comparator product




Primary Outcome Measures :
  1. Leakage (Percentage of All Baseplates With Leakage) [ Time Frame: After each baseplate change over a period, of 7 days ]

    leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate.

    The subjects tick of one of the four possible answers:

    1. No leakage
    2. Starting to leak (leakage under the baseplate)
    3. Leakage (seepage of faeces resulting in leakage on clothes)
    4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Be able to handle the bags themselves
  4. Have an ileostomy with a diameter between 15 and 55 mm
  5. Have had their ileostomy for at least 3 months
  6. Currently use a 1-piece flat ostomy appliance with open bag
  7. Use minimum 1 product every second day, i.e. maximum 2 days wear time
  8. Be suitable for participation in the study and for using a standard adhesive, flat base plate
  9. Must be able and willing to use custom cut products
  10. Accept to test two 1-piece products within the study period

Exclusion Criteria:

  1. Use irrigation during the study period (flush the intestines with water)
  2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
  3. Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
  4. Are pregnant or breastfeeding
  5. Participating in other interventional clinical investigations or have previously participated in this investigation
  6. Currently using a ostomy belt
  7. Currently using extended wear product
  8. Have a loop ileostomy
  9. Known hypersensitivity towards any of the test products
  10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799239


Locations
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Sweden
Skövde Hospital
Skövde, Sweden, 541 85
Sponsors and Collaborators
Coloplast A/S
Investigators
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Study Chair: Daniel Carter, MSc Coloplast A/S
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01799239    
Other Study ID Numbers: CP237
First Posted: February 26, 2013    Key Record Dates
Results First Posted: December 5, 2013
Last Update Posted: September 30, 2016
Last Verified: August 2016
Keywords provided by Coloplast A/S:
stoma ileostomy