Investigating the Adhesion of New Adhesive to the Skin

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

The adhesion of the new adhesive strips is investigated on healthy volunteers

Study Overview

• Status: Unknown
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: PL4; Other: PL16-L

Detailed Description

Inclusion visit:

• Introduction to the study
• Inclusion in study
• Baseline information is obtained
• Instruct subject to pre-strip of abdominal skin

Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):

• Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
• Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
• Adhesive strips are weighted and applied
• Potential shower/bicycle exercise (max 60 minutes)
• Adhesive strips are removed at pre-defined timeslots (peel force measured)
• Discomfort when strip was peeled of is evaluated by subject (VAS)
• Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
• Acclimatization ½
• Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
• Adhesive strips are weighed
• Photo of adhesive strips

The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test of new adhesive strips; The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L	Other: Standard adhesive 1; This strip contains a standard hydrocolloid adhesive found in ostomy devices; Other: Standard adhesive 2; This strip contains a standard hydrocolloid adhesive found in ostomy devices; Other: PL4; This strip contains a new adhesive; Other: PL16-L; This strip contains a new adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling of the adhesive	Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)	24 hours

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Lene F Nielsen, Head of the pre-clinical department

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): February 15, 2018
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP267_3_5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No