Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

NCT02362360 | Completed Results

• 1 other identifier: CP255
• Study Type: interventional
• Target: 52
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.

Conditions

Ileostomy; Colostomy

Keywords

Ostomy

Outcome Measures

Primary Outcomes (1)

• Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".

  Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".

  21 +/- 3 days

Study Arms (2)

Coloplast Test Product then Comparator

EXPERIMENTAL

The subject first tests the Coloplast Test Product and then tests the Comparator

Device: Coloplast Test Product; Device: Comparator (Hollister)

Comparator then Coloplast Test Product

EXPERIMENTAL

The subject first tests the Comparator and then tests the Coloplast Test Product.

Device: Coloplast Test Product; Device: Comparator (Hollister)

Interventions

Coloplast Test Product DEVICE

A new 2-piece ostomy appliance developed by Coloplast A/S

Coloplast Test Product then Comparator; Comparator then Coloplast Test Product

Comparator (Hollister) DEVICE

Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.

Coloplast Test Product then Comparator; Comparator then Coloplast Test Product

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 in DK: signed a 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
• Able to use a baseplate size 15 to 40 mm
• Be able to handle the product themselves
• Normally experience faeces under the baseplate at least 3 times during 2 weeks
• Currently using a 2-piece flat product with mechanical coupling
• Willing to test both the Coloplast test product and the comparator product
• Willing to use an open bag size maxi during the investigation
• Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
• Willing to use at least 1 baseplate every 3rd day during the investigation
• Is able to use a custom cut product
• Be suitable for participating in the investigation

You may not qualify if:

• Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
• Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
• 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 peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
• Have a loop ostomy
• Have known hypersensitivity towards any of the products used in the investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (5)

Trial Form Support ApS (TFS)

Soeborg, 2860, Denmark

Location

Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie

Berlin, 12203, Germany

Location

SIEWA Coloplast Homecare

Hamburg, 22045, Germany

Location

QPS Netherlands

Groningen, 9713G12, Netherlands

Location

Sykepleierklinikken A/S, Larvik

Larvik, 3269, Norway

Location

Related Publications (1)

• Rolfsen T, Vestergaard M, Hansen MF, Boisen EB, Dambaek MR. Body Fit With a Pouching System With Concave Contour for People With an Outward Peristomal Body Profile: Effects on Leakage, Wear Time, and Quality of Life: A Randomized Controlled Cross-Over Trial. J Wound Ostomy Continence Nurs. 2024 Jul-Aug 01;51(4):303-311. doi: 10.1097/WON.0000000000001088. Epub 2024 Jul 19.

  PMID: 39037163 DERIVED

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: Coloplast

dkcfv@coloplast.com

0045 49111990

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: 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: February 9, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 11, 2016
• Results First Posted: October 11, 2016

Record last verified: 2016-08

Locations

NO (1); NL (1); DK (1); DE (2)