Evaluation of the Performance of a New 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: NCT03257787
• Other study ID #: CP265_15
• Status: Completed
• Phase: N/A
• First received: August 18, 2017
• Last updated: November 7, 2017
• Start date: August 8, 2017
• Est. completion date: September 23, 2017

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 23, 2017
• Est. primary completion date: August 23, 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 a stoma for more than one year

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

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

6. Have a peristomal area accessible for application of 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. Actively 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 is a strip 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	The trans epidermal water loss is a measure of the skins barrier function. There is always a loss of water from the skin due to evaporation. However, when the barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess damage to the skin.	8 hours