An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Strip A; Other: Strip B; Other: Strip C

• Registration Number: NCT02818257
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Primary Completion: 2018-10-13
• Study Completion: 2018-10-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have intact skin on the area used in the investigation

Exclusion Criteria

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
• Are pregnant or breastfeeding
• Having dermatological problems in the abdominal area (assessed by investigator)
• Participate in other clinical investigations or have previously participated in this investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Strip A (dry)	Strip A	Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)
Strip B (dry)	Strip B	Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)
Strip C (dry)	Strip C	Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips)
Strip A (wet)	Strip A	Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each)
Strip B (wet)	Strip B	Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each)
Strip C (wet)	Strip C	Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each)

Primary Outcome Measures

Name	Time	Method
Peel force used to removed adhesive	60 min	The three strips applied to skin that has received the same treatment (either buffer 1, buffer 2 or dry) are removed at three different time points (max 60 min) and the peel force is measured.; Peel force (90 degree angle from skin) The tensile tester was mounted on a tripod under which the subject was lying. In this way the tensile tester measures the force (Newton), which was needed to remove the adhesive from the skin with a constant speed and with a mean angel of 90°

Trial Locations

Locations (1)

Coloplast; 🇩🇰 Humlebæk, Denmark