An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

Coloplast

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Strip B; Other: Strip C; Other: Strip A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02818257

CP263

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 6 patient groups

Strip A (wet)

Experimental group

Description:

Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each)

Treatment:

Other: Strip A

Strip A (dry)

Experimental group

Description:

Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)

Treatment:

Other: Strip A

Strip B (wet)

Experimental group

Description:

Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each)

Treatment:

Other: Strip B

Strip B (dry)

Experimental group

Description:

Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)

Treatment:

Other: Strip B

Strip C (wet)

Experimental group

Description:

Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each)

Treatment:

Other: Strip C

Strip C (dry)

Experimental group

Description:

Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips)

Treatment:

Other: Strip C