An Exploratory Study Investigating Adhesive Reaction to Output
1 other identifier
interventional
15
1 country
1
Brief Summary
The objective is to investigate the impact that faecal output has on adhesives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 30, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 20, 2016
January 1, 2016
3 months
October 30, 2015
January 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Remaining adherent area of the adhesive
The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling.
8 hours
Study Arms (6)
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
EXPERIMENTALThe 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
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
EXPERIMENTALThe 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
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
EXPERIMENTALThe 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
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
EXPERIMENTALThe 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
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
EXPERIMENTALThe 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
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
EXPERIMENTALThe 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
Interventions
Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip
Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast A/S
Humlebæk, 3050, Denmark
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Birte P Jakobsen, MD
Medical Director
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2015
First Posted
November 2, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 20, 2016
Record last verified: 2016-01