An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strip A

Other

Adhesive strip A

Strip B

Other

Adhesive strip B

Strip C

Other

Adhesive strip C

Primary outcomes

Peel force used to removed adhesive

Time frame: 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°

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jun 29, 2016
Registry last updated: Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed