Evaluation of the Effect of Output on Newly Developed Adhesives

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Other: Standard hydrocolloid adhesive; Other: P-4; Other: P-15; Other: P-16

• Registration Number: NCT03200418
• Lead Sponsor: Coloplast A/S

Brief Summary

The study investigates the impact real output has on the adhesion of the adhesives.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study Start: 2017-06-27
• Study First Posted: 2017-06-27
• Primary Completion: 2017-09-04
• Study Completion: 2017-09-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test of new adhesives	Standard hydrocolloid adhesive	On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output. The difference between the four patches is that they consist of different adhesives. One patch is made of a standard hydrocolloid adhesive The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16
Test of new adhesives	P-16	On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output. The difference between the four patches is that they consist of different adhesives. One patch is made of a standard hydrocolloid adhesive The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16
Test of new adhesives	P-4	On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output. The difference between the four patches is that they consist of different adhesives. One patch is made of a standard hydrocolloid adhesive The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16
Test of new adhesives	P-15	On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output. The difference between the four patches is that they consist of different adhesives. One patch is made of a standard hydrocolloid adhesive The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	8 hours	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.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark