Clinical trial NCT01243294: Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
Official title: Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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 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

Primary outcomes:
measure: Leakage (Percent of All Base Plates With Leakage)
timeFrame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Secondary outcomes:
measure: Adverse Events
timeFrame: During the investigation ~ 24 days per subject
measure: Security (Subjects Own Assessment)
timeFrame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
measure: Handling at Appliance (Subjects Own Assessment)
timeFrame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
measure: Comfort (Subjects Own Assessment)
timeFrame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
measure: Wear Time (Registered by Subject When Applying and Removing a Product)
timeFrame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Pia Nordmand, MSc
role: PRINCIPAL_INVESTIGATOR
References: