An Exploratory Study Investigating Adhesive Reaction to Output
Status
Completed
Conditions
Ileostomy
Treatments
Other: Patch 4
Other: Patch 2
Other: Patch 6
Other: patch 5
Other: Patch 1
Other: Patch 3
Details and patient eligibility
About
The objective is to investigate the impact that faecal output has on adhesives.
Enrollment
15 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
- Have had an ileostomy for more than 3 months
- Have intact skin on the area used in the evaluation
- Has an ileostomy with a diameter (≤) 35mm
Exclusion criteria
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal area
- Convex user
- Participate in other interventional clinical investigations
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
15 participants in 6 patient groups
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
Experimental group
Description:
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
Treatment:
Other: Patch 4
Other: Patch 3
Other: Patch 2
Other: Patch 1
Other: Patch 6
Other: patch 5
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
Experimental group
Description:
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
Treatment:
Other: Patch 4
Other: Patch 3
Other: Patch 2
Other: Patch 1
Other: Patch 6
Other: patch 5
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
Experimental group
Description:
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
Treatment:
Other: Patch 4
Other: Patch 3
Other: Patch 2
Other: Patch 1
Other: Patch 6
Other: patch 5
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
Experimental group
Description:
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
Treatment:
Other: Patch 4
Other: Patch 3
Other: Patch 2
Other: Patch 1
Other: Patch 6
Other: patch 5
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
Experimental group
Description:
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
Treatment:
Other: Patch 4
Other: Patch 3
Other: Patch 2
Other: Patch 1
Other: Patch 6
Other: patch 5
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
Experimental group
Description:
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
Treatment:
Other: Patch 4
Other: Patch 3
Other: Patch 2
Other: Patch 1
Other: Patch 6
Other: patch 5
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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