An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

NCT02351817 | Completed Results

• 1 other identifier: CP256
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.

Conditions

Ileostomy

Outcome Measures

Primary Outcomes (1)

• Product Acceptance

  Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product

  7 days per test period

Study Arms (2)

Baseline - Test A - Test B

EXPERIMENTAL

Three period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces

Device: Test A; Device: Test B; Device: Baseline

Baseline - Test B - Test A

EXPERIMENTAL

First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces

Device: Test A; Device: Test B; Device: Baseline

Interventions

Test A DEVICE

Ostomy appliance

Baseline - Test A - Test B; Baseline - Test B - Test A

Test B DEVICE

Ostomy appliance

Baseline - Test A - Test B; Baseline - Test B - Test A

Baseline DEVICE

Ostomy appliance

Baseline - Test A - Test B; Baseline - Test B - Test A

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 and letter of authority
• Be at least 18 years of age and have full legal capacity
• Be able to handle the products her/himself
• Have an ileostomy with a diameter between 10 and 30 mm
• Willing to follow the product change schedule (one change per day)
• Have had their ostomy for at least three months
• Willing to use 1 piece open ostomy products during the test period
• Must be able to use a custom cut product
• Have intact skin
• Negative result of a pregnancy test for women of childbearing age

You may not qualify if:

• Currently receiving or have within the past 2 months 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
• Is pregnant or breastfeeding.
• Is participating in other interventional clinical investigations or have previously participated in this investigation
• Have a loop ileostomy
• Known hypersensitivity towards any of the test products

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Medical Director
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 4911 1395

Study Officials

• Birte Petersen Jakobsen, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 6, 2016
• Results First Posted: November 30, 2015

Record last verified: 2015-12

Locations

DK (1)