Investigating the Adhesion of New Adhesive to the Skin

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03439176
• Other study ID #: CP267_3_5
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2020
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: June 30, 2020
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Other:
• Standard adhesive 1
This strip contains a standard hydrocolloid adhesive found in ostomy devices
• Standard adhesive 2
This strip contains a standard hydrocolloid adhesive found in ostomy devices
• PL4
This strip contains a new adhesive
• PL16-L
This strip contains a new adhesive

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swelling of the adhesive	Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)	24 hours