Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)

NCT02992444 | Completed

• 1 other identifier: CP265_05
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the impact real output has on peristomal skin covered by an adhesive

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Trans epidermal water loss

  The skins barrier function is measured using trans epidermal water loss after removing the adhesive from the skin

  4 - 24 hours

Study Arms (1)

Cohort 5

EXPERIMENTAL

This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 8 hours. There is one visit: Two adhesive strips (standard adhesive strip and Experimental adhesive strip)are applied on the peristomal skin and allowed to sit for 8hours before being removed.

Other: Standard adhesive strip; Other: Experimental adhesive strip

Interventions

Standard adhesive strip OTHER

This is a standard adhesive strip (hydrocolloid)

Cohort 5

Experimental adhesive strip OTHER

This is a strip of a newly developed adhesive.

Cohort 5

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 an ileostomy for more than one year
• Have intact skin on the area used in the evaluation
• Has an ileostomy 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)
• Participating in other interventional clinical investigations or have previously participated in this evaluation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Study Officials

• Lene Feldskov, M. Sci

  Senior R&D Scientist

  PRINCIPAL INVESTIGATOR

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: December 12, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 28, 2025

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)