A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

NCT02610907 | Completed

• 1 other identifier: CP265_01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.

Conditions

Ileostomy

Outcome Measures

Primary Outcomes (1)

• Remaining adhesive area of adhesive

  The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.

  30 hours

Study Arms (1)

Cohort 01a

EXPERIMENTAL

This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.

Other: Buffer; Other: Own output; Other: simulated output

Interventions

Buffer OTHER

The sleeve contains phosphate buffered saline buffer

Cohort 01a

Own output OTHER

The sleeve contains the subject own ileal effluent

Cohort 01a

simulated output OTHER

The sleeve contains simulated output

Cohort 01a

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

MeSH Terms

Interventions

Buffers

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Lene F Nielsen, MSc

  R&D Principal 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: November 16, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

DK (1)