Assessment of the Effect of Output on New Adhesives

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Other: Standard hydrocolloid adhesive patch; Other: LT-2; Other: LT-21; Other: 33-20

• Registration Number: NCT03331783
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-27
• Primary Completion: 2017-10-17
• Study Completion: 2017-10-17
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have had a stoma for more than one year
• Have intact skin on the area used in the evaluation
• Has a stoma with a diameter up to (≤) 35 mm
• Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• Are pregnant or breastfeeding
• Having dermatological problems in the peri-stomal- or abdominal area (assessed by investigating scientist)
• 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 adhesive strips	Standard hydrocolloid adhesive patch	On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output. The difference between the four patches is that they are made of four different adhesives. The primary endpoint is measured after 8 hours and 24 hours.
Test of new adhesive strips	33-20	On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output. The difference between the four patches is that they are made of four different adhesives. The primary endpoint is measured after 8 hours and 24 hours.
Test of new adhesive strips	LT-21	On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output. The difference between the four patches is that they are made of four different adhesives. The primary endpoint is measured after 8 hours and 24 hours.
Test of new adhesive strips	LT-2	On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output. The difference between the four patches is that they are made of four different adhesives. The primary endpoint is measured after 8 hours and 24 hours.

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 will increase leading to an increase in the trans epidermal water loss.Thus, trans epidermal water loss is used to assess the damage to the skin. Maesurents are taken at time 0 and after 8 hours of output exposure to the skin.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark