The Influence of Adhesive Wafer Design on Fit to the Body

NCT02176954 | Completed

• 1 other identifier: CP247
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 10

Brief Summary

The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..

Conditions

Ostomy - Ileostomy or Colostomy

Outcome Measures

Primary Outcomes (1)

• Fit to body

  Subjects will evaluate the fit to body for each product by answering the question "How was the base plates ability to fit the body contours in the area around the stoma?" The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.

  14 +/- 2 days

Study Arms (6)

Test A, Test B, Comparator

EXPERIMENTAL

The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator.

Device: Test A; Device: Test B; Device: Comparator

Test A, Comparator, Test B

EXPERIMENTAL

The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B.

Device: Test A; Device: Test B; Device: Comparator

Test B, Test A, Comparator

EXPERIMENTAL

The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator.

Device: Test A; Device: Test B; Device: Comparator

Test B, Comparator, Test A

EXPERIMENTAL

The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B.

Device: Test A; Device: Test B; Device: Comparator

Comparator, Test A, Test B

EXPERIMENTAL

The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B

Device: Test A; Device: Test B; Device: Comparator

Comparator, Test B, Test A

EXPERIMENTAL

The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A.

Device: Test A; Device: Test B; Device: Comparator

Interventions

Test A DEVICE

Test A is a new 1-piece ostomy appliance developed by Coloplast A/S

Comparator, Test A, Test B; Comparator, Test B, Test A; Test A, Comparator, Test B; Test A, Test B, Comparator; Test B, Comparator, Test A; Test B, Test A, Comparator

Test B DEVICE

Test B is a new 1-piece ostomy appliance developed by Coloplast A/S

Comparator, Test A, Test B; Comparator, Test B, Test A; Test A, Comparator, Test B; Test A, Test B, Comparator; Test B, Comparator, Test A; Test B, Test A, Comparator

Comparator DEVICE

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available. Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.

Comparator, Test A, Test B; Comparator, Test B, Test A; Test A, Comparator, Test B; Test A, Test B, Comparator; Test B, Comparator, Test A; Test B, Test A, Comparator

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 signed letter of Authority
• Be at least 18 years of age and have full legal capacity
• Have had their ileostomy or colostomy for at least 3 months
• Have a stoma with a diameter between 15 and 43 mm
• Be able to handle the product themselves
• Be able to use a custom cut product
• Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
• Currently using a 1-piece flat product or a 1-piece soft convex product
• Be willing to test products with open bag size maxi
• Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
• Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
• Be suitable for participating in the investigation
• Be willing to take/have taken pictures of the stoma before, during and after application of product

You may not qualify if:

• Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
• Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
• Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
• Are pregnant or breastfeeding
• Are participating in other interventional clinical investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestines with water)
• Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
• Have a loop stoma
• Have known hypersensitivity towards any of the test products

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (10)

QPS Netherlands

Groningen, 9713, Netherlands

Location

Synexus Thames Valley

Berkshire, RG2 0TG, United Kingdom

Location

Synexus Midlands

Birmingham, B15 2SQ, United Kingdom

Location

Synexus Wales

Cardiff, CF14 5GJ, United Kingdom

Location

Synexus Scotland

Glasgow, G20 0SP, United Kingdom

Location

Cheltenham General Hospital

Gloucestershire, G1537AN, United Kingdom

Location

Synesxus Lancashire

Lancashire, PR7 7NA, United Kingdom

Location

Synexus Merseyside

Liverpool, L22 0LG, United Kingdom

Location

Synexus Manchester

Manchester, M15 6SX, United Kingdom

Location

Synexus North East

Northumberland, NE46 1QJ, United Kingdom

Location

Study Officials

• Khalid Abd-Elaziz, MD

  QPS Netherlands

  PRINCIPAL INVESTIGATOR

• Susanne Eyre, MD

  Synexus North East, United Kingdom

  PRINCIPAL INVESTIGATOR

• Gillian Hopkins

  Cheltenham General Hospital, United Kingdom

  PRINCIPAL INVESTIGATOR

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: June 26, 2014
• First Posted: June 27, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

NL (1); GB (9)