Evaluation of the Effect of Output on Newly Developed Adhesives

NCT03200418 | Completed

• 1 other identifier: CP265_10_11
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the impact real output has on the adhesion of the 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 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.

  8 hours

Study Arms (1)

Test of new adhesives

EXPERIMENTAL

On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output. The difference between the four patches is that they consist of different adhesives. One patch is made of a standard hydrocolloid adhesive The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16

Other: Standard hydrocolloid adhesive; Other: P-4; Other: P-15; Other: P-16

Interventions

Standard hydrocolloid adhesive OTHER

This patch is made of standard hydrocolloid adhesive

Test of new adhesives

P-4 OTHER

This patch is made of new adhesive

Test of new adhesives

P-15 OTHER

This patch is made of new adhesive

Test of new adhesives

P-16 OTHER

This patch is made of new adhesive

Test of new adhesives

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 (tab-let/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

MeSH Terms

Interventions

Cyclin-Dependent Kinase Inhibitor p15; Cyclin-Dependent Kinase Inhibitor p16

Intervention Hierarchy (Ancestors)

Cyclin-Dependent Kinase Inhibitor Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Cell Cycle Proteins; Proteins; Tumor Suppressor Proteins; Neoplasm Proteins

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 27, 2017
• Primary Completion: September 4, 2017
• Study Completion: September 4, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)