Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: LT-2; Other: LT-21; Other: LT-25; Other: 33-20

• Registration Number: NCT03289013
• Lead Sponsor: Coloplast A/S

Brief Summary

This study investigates the adhesion of new adhesives to the skin.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-11
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-20
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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
Testing of new adhesive strips	Standard adhesive 1	Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Testing of new adhesive strips	33-20	Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Testing of new adhesive strips	LT-2	Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Testing of new adhesive strips	LT-21	Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Testing of new adhesive strips	Standard adhesive 2	Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Testing of new adhesive strips	LT-25	Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.

Primary Outcome Measures

Name	Time	Method
Swelling of the adhesive	21 days	1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark