An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

NCT02818257 | Completed

• 1 other identifier: CP263
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Peel force used to removed adhesive

  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°

  60 min

Study Arms (6)

Strip A (wet)

EXPERIMENTAL

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

Other: Strip A

Strip A (dry)

EXPERIMENTAL

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

Other: Strip A

Strip B (wet)

EXPERIMENTAL

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

Other: Strip B

Strip B (dry)

EXPERIMENTAL

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

Other: Strip B

Strip C (wet)

EXPERIMENTAL

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

Other: Strip C

Strip C (dry)

EXPERIMENTAL

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

Other: Strip C

Interventions

Strip A OTHER

Adhesive strip A

Strip A (dry); Strip A (wet)

Strip B OTHER

Adhesive strip B

Strip B (dry); Strip B (wet)

Strip C OTHER

Adhesive strip C

Strip C (dry); Strip C (wet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast

Humlebæk, 3050, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: October 13, 2018
• Study Completion: October 13, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)