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

Coloplast

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colostomy

Treatments: Device: SenSura; Device: SS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243294

CP209OC

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

56 participants in 2 patient groups

SenSura

Active Comparator group

Description:

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.

Treatment:

Device: SenSura

Device: SS

New ostomy appliance (SS)

Active Comparator group

Description:

SS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names.

Treatment:

Device: SenSura

Device: SS