Investigating the Adhesion of New Adhesive to the Skin

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03439176

Enrollment

Registered

2018-02-20

Start date

2018-01-15

Completion date

2020-06-30

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy - Stoma

Brief summary

The adhesion of the new adhesive strips is investigated on healthy volunteers

Detailed description

Inclusion visit: * Introduction to the study * Inclusion in study * Baseline information is obtained * Instruct subject to pre-strip of abdominal skin Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin): * Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip) * Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Adhesive strips are weighted and applied * Potential shower/bicycle exercise (max 60 minutes) * Adhesive strips are removed at pre-defined timeslots (peel force measured) * Discomfort when strip was peeled of is evaluated by subject (VAS) * Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Acclimatization ½ * Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Adhesive strips are weighed * Photo of adhesive strips The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

Interventions

OTHERStandard adhesive 1

This strip contains a standard hydrocolloid adhesive found in ostomy devices

OTHERStandard adhesive 2

This strip contains a standard hydrocolloid adhesive found in ostomy devices

OTHERPL4

This strip contains a new adhesive

OTHERPL16-L

This strip contains a new adhesive

Study design

Allocation

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
Swelling of the adhesive	24 hours	Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026