Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives

NCT02886455 | Completed

• 1 other identifier: CP265_04
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Trans epidermal water loss

  The condition of the skin (transepidermal water loss) is measured after removing the adhesive by TE

  4-24 hours

Study Arms (1)

Cohort 4

EXPERIMENTAL

This is a sub-study testing the effect of real output applied under two adhesive strips on the skin at two different time points (4 and 24 hours). There are two visits: Visit 1: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 4 hours before being removed Visit 2: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 24 hours before being removed

Other: Standard adhesive strip; Other: New adhesive strip

Interventions

Standard adhesive strip OTHER

This is a standard adhesive strip (hydrocolloid)

Cohort 4

New adhesive strip OTHER

This a newly developed adhesive strip.

Cohort 4

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 F Nielsen, Msc

  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: August 29, 2016
• First Posted: September 1, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

DK (1)