Evaluation of the Influence of Output on Skin Wearing a New Adhesive

NCT03200431 | Completed

• 1 other identifier: CP265_16
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Trans epidermal water loss

  The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran 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.

  24 hours

Study Arms (1)

Test of a new adhesive strip

EXPERIMENTAL

This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 24 hours. The adhesive strip is not yet part of a marketed ostomy device.

Other: New adhesive strip

Interventions

New adhesive strip OTHER

This is a newly developed strip.

Test of a new adhesive strip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 evalua-tion
• 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)

You may not qualify if:

• 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 peristomal- or abdominal area (assessed by investigating scientist)
• Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 27, 2017
• Study Start: June 26, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)