Evaluation of the Effect of Output on Newly Developed Adhesives

Ileostomy - Stoma Clinical Trial

Official title:

Evaluation of the Effect of Output on Newly Developed Adhesives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200418
• Other study ID #: CP265_10_11
• Status: Completed
• Phase: N/A
• First received: June 26, 2017
• Last updated: November 7, 2017
• Start date: June 27, 2017
• Est. completion date: September 4, 2017

Study information

• Verified date: November 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 the adhesion of the adhesives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 4, 2017
• Est. primary completion date: September 4, 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 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 (tab-let/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:
• Standard hydrocolloid adhesive
This patch is made of standard hydrocolloid adhesive
• P-4
This patch is made of new adhesive
• P-15
This patch is made of new adhesive
• P-16
This patch is made of new adhesive

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 trans epidermal water loss is measured on the peristomal skin using a probe. The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.	8 hours