Evaluation of the Peel Force of New Adhesives From the Skin

Not Applicable

Completed

• Conditions: Stoma Ileostomy
• Interventions: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: Standard adhesive 3; Other: P-4; Other: P-15; Other: P-16

• Registration Number: NCT03200444
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Study Start: 2017-07-03
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Results First Submitted: 2023-09-19
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Results First Posted: 2025-04-25
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• 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
Testing of 6 adhesive strips	Standard adhesive 2	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.
Testing of 6 adhesive strips	Standard adhesive 3	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.
Testing of 6 adhesive strips	Standard adhesive 1	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.
Testing of 6 adhesive strips	P-4	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.
Testing of 6 adhesive strips	P-15	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.
Testing of 6 adhesive strips	P-16	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.

Primary Outcome Measures

Name	Time	Method
Peel Force	30 min	The peel force (N) needed to peel off adhesive strips from the skin

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark