Stoma Ileostomy
Conditions
Brief summary
This study investigates the impact and adhesion of new adhesives to the skin.
Interventions
OTHERStandard adhesive 1
This strip consists of a standard hydrocolloid adhesive found in ostomy products
OTHERStandard adhesive 2
This strip consists of a standard hydrocolloid adhesive found in ostomy products
OTHERStandard adhesive 3
This strip consists of a standard hydrocolloid adhesive found in ostomy products
OTHERP-4
Newly developed adhesive P-4
OTHERP-15
Newly developed adhesive P-14
OTHERP-16
Newly developed adhesive P-8
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have intact skin on the area used in the investigation
Exclusion criteria
1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy 2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment. 3. Are pregnant or breastfeeding 4. Have dermatological problems in the abdominal area (assessed by investigator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peel Force | 30 min | The peel force (N) needed to peel off adhesive strips from the skin |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testing of 6 Adhesive Strips Each subject tests six adhesive strips on pre-striped skin.
1. Standard adhesive 1
2. standard adhesive 2
3. Standard adhesive 3
4. P-4
5. P-15
6. P-16
The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits.
Standard adhesive 1: This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 2: This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 3: This strip consists of a standard hydrocolloid adhesive found in ostomy products
P-4: Newly developed adhesive P-4
P-15: Newly developed adhesive P-14
P-16: Newly developed adhesive P-8 | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Testing of 6 Adhesive Strips |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Region of Enrollment Denmark | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Peel Force
The peel force (N) needed to peel off adhesive strips from the skin
Time frame: 30 min
Population: All participants were analysed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Adhesive 1 | Peel Force | 5.2 Newton |
| Standard Adhesive 2 | Peel Force | 3 Newton |
| Standard Adhesive 3 | Peel Force | 2.1 Newton |
| P-4 Adhesive | Peel Force | 3.3 Newton |
| P-15 Adhesive | Peel Force | 3.7 Newton |
| P-16 Adhesive | Peel Force | 4.4 Newton |