Evaluation of the Performance of an Adhesive Strip

Ileostomy - Stoma Clinical Trial

Official title:

A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419013
• Other study ID #: CP265_18
• Status: Completed
• Phase: N/A
• First received: January 15, 2018
• Last updated: January 31, 2018
• Start date: January 10, 2018
• Est. completion date: January 22, 2018

Study information

• Verified date: January 2018
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigated the performance of a new adhesive strip when impacted by output

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 22, 2018
• Est. primary completion date: January 22, 2018
• 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 test product (assessed by investigator)

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 investigator)

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

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Other:
• New adhesive strip
This strip is made of a newly developed 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	Trans epidermal water loss	trans epidermal water loss is a measure of the skins barrier function. There is always a oss of water from the skin due to evaporation. However, when the skin barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess the skins barrier function	24 hours