Clinical trial NCT04101318: Investigation of a New Stoma Product for People With a Stoma
Official title: Investigation of a New Stoma Product for People With a Stoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peristomal Skin Complication
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2019-09-24
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.

Detailed description: Enrolled participant with an ileostomy or colostomy with liquid output were randomized to test either the non-Conformité Européene marked investigational product or one of the five comparators Conformité Européene marked products first and then will be crossed over to receive the opposite intervention.

The participant will first be included in an information and inclusion visit (V0) and after signing all consent forms will complete three test visits (V1, V2, and V3). Each participant will be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a maximum of 90 days.

The study is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation with two test periods. The study was conducted in four different countries (UK, Germany, Italy, and Norway) with a total of six sites participating.

The study is now complete.

Eligibility criteria: Inclusion Criteria:

1. Has given informed consent to participate by signing the informed consent signature form.
2. Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale)
3. Currently using a flat product
4. Be at least 18 years of age and have full legal capacity
5. Have had their stoma for at least three months (90 days)
6. Can use a product with a max cut size of 40 mm
7. Has experienced leakage\* under the baseplate at least three times within the last 14 days. \*leakage defined as output seeping under the baseplate (Appendix 6 - Classification of leakage)
8. Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below

   1. Has experienced symptoms of skin complications (itching, burning, pain) within the last fourteen days
   2. Has experienced red skin in the inner circle (within three cm from stoma edge) within the last fourteen days
   3. Has skin complication (assessed by Principal Investigator, or delegate) in the inner circle (within three cm from stoma edge) of the peristomal area
9. Is able to handle the electronic diary (questionnaire/ photo) themselves.
10. Is able to handle (apply, remove, cut etc.) the product themselves
11. Is willing to not use barrier film or barrier cream during the investigation
12. Is willing and suitable (determined by Principal Investigator, or delegate) to use a flat custom cut one-piece open or a two-piece open product during the investigation.
13. Is willing to change the product (1pc) or baseplate (2pc) at least every fourth days.

Exclusion Criteria:

1. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy

   - low doses chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.
2. Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray.

   * Low dose systemic steroid treatment (e.g. inhalation) assessed by the Principal Investigator are allowed.
   * Other systemic steroid treatment (e.g. injection, or tablet) are not allowed.
3. Is breastfeeding
4. Is pregnant (based on pregnancy test -urine)
5. Has known hypersensitivity towards any of the products used in the investigation

   -

Primary outcomes:
measure: Max Itching Within a Week at Steady State
timeFrame: Within a week at steady state
Secondary outcomes:
measure: Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment
timeFrame: past 14 days by end of treatment
measure: Max Pain Within a Week at Steady State
timeFrame: Within one week at steady state
measure: Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment
timeFrame: past 14 days by end of treatment
measure: Max Burning Within a Week at Steady State
timeFrame: Within one week at steady state
measure: Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment
timeFrame: past 14 days by end of treatment
measure: Bleeding Around the Ostomy at Each Baseplate Change at Steady State
timeFrame: Within one week at steady state
measure: Weeping Around the Ostomy at Each Baseplate Change at Steady State
timeFrame: Within one week at steady state
measure: Ulcers Around the Ostomy at Each Baseplate Change at Steady State
timeFrame: Within one week at steady state
measure: Max Overall Physical Discomfort Within a Week Per Baseplate Change at Steady State
timeFrame: Within one week at steady state
measure: Max Overall Ability to Move Around Within a Week Per Baseplate Change at Steady State
timeFrame: Within one week at steady state
measure: Max Overall Ability to Stick the Stoma Bag Adhesive to the Skin Within a Week Per Baseplate Change at Steady State
timeFrame: Within one week at steady state
measure: Discoloration Area (cm^2) Per Baseplate Change at Steady State
timeFrame: 3 weeks
measure: Intensity of Discolorated Area Scored Per Baseplate Change at Steady State After Three Weeks of Product Use
timeFrame: 3 weeks
measure: Total Discoloration, Erosion, and Tissue Overgrowth (DET) Score by End of Treatment at Steady State
timeFrame: 3 weeks
measure: Discoloration Item Score by End of Treatment at Steady State
timeFrame: 3 weeks
measure: Erosion Item Score by End of Treatment at Steady State
timeFrame: 3 weeks
measure: Tissue Overgrowth Item Score by End of Treatment at Steady State
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Larvik
country: Norway
facility: Ragene Saetre
Study officials:
affiliation: Coloplast A/S
name: Nazarena Mazzarro, MD
role: STUDY_DIRECTOR
References: