Evaluation of the Influence of New Adhesives of Output on Skin

Stoma Ileostomy Clinical Trial

Official title:

Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044262
• Other study ID #: CP265_07
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: May 29, 2017
• Start date: January 9, 2017
• Est. completion date: April 25, 2017

Study information

• Verified date: May 2017
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: No
• 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 had an ileostomy for more than one year

4. Have intact skin on the area used in the evaluation

5. Has an ileostomy with a diameter up to (=) 35 mm

6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy

2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.

3. Are pregnant or breastfeeding

4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)

5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Other:
• Standard adhesive strip
This is a standard adhesive strip (hydrocolloid) that is part of an ostomy device
• New adhesive strip
This is a newly developed adhesive strip that in the future might be part of an ostomy device

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebaek

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trans epidermal water loss	The condition of the skin (trans epidemeral water loss) is measured after removing the adhesive.	8 hours