Investigating the Adhesion of New Adhesive to the Skin

Not Applicable

• Conditions: Ileostomy - Stoma
• Interventions: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: PL4; Other: PL16-L

• Registration Number: NCT03439176
• Lead Sponsor: Coloplast A/S

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.

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-01-31
• Primary Completion: 2018-02-15
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test of new adhesive strips	PL16-L	The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L
Test of new adhesive strips	Standard adhesive 1	The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L
Test of new adhesive strips	Standard adhesive 2	The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L
Test of new adhesive strips	PL4	The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L

Primary Outcome Measures

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

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark