Assessment of the Effect of Output on New Adhesives

NCT03331783 | Completed

• 1 other identifier: CP265_21_22
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

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 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.

  8 hours

Study Arms (1)

Test of new adhesive strips

EXPERIMENTAL

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.

Other: Standard hydrocolloid adhesive patch; Other: LT-2; Other: LT-21; Other: 33-20

Interventions

Standard hydrocolloid adhesive patch OTHER

This patch is made of a standard hydrocolloid adhesive

Test of new adhesive strips

LT-2 OTHER

This patch is made of a new adhesive

Test of new adhesive strips

LT-21 OTHER

This patch is made of a new adhesive

Test of new adhesive strips

33-20 OTHER

This patch is made of a new adhesive

Test of new adhesive strips

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 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)

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 peri-stomal- 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

MeSH Terms

Interventions

cholecystokinin 33 (10-20)

Study Officials

• Lene Feldskov

  Head of preclinical department

  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: November 1, 2017
• First Posted: November 6, 2017
• Study Start: September 27, 2017
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

DK (1)