Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece

NCT01957488 | Completed Results

• 1 other identifier: CP242
• Study Type: interventional
• Target: 183
• Locations: 4 countries
• Sites: 4

Brief Summary

The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Leakage

  The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.

  14 +- 1 days

Study Arms (3)

Treatment sequence 1; First Coloplast Test product 1

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 1 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 2

Device: Coloplast Test Product 1; Device: Coloplast Test Product 2; Device: Coloplast SenSura

Treatment seqence 2; First Coloplast Test product 2.

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 2 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 1

Device: Coloplast Test Product 1; Device: Coloplast Test Product 2; Device: Coloplast SenSura

Treatment sequence 3, First Coloplast SenSura

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast SenSura and secondly test either: 1. Coloplast Test product 2 and thereafter Coloplast Test product 1 2. Coloplast Test product 1 and thereafter Coloplast Test product 2

Device: Coloplast Test Product 1; Device: Coloplast Test Product 2; Device: Coloplast SenSura

Interventions

Coloplast Test Product 1 DEVICE

Coloplast Test product 1 is a newly developed 1-piece ostomy appliance

Treatment seqence 2; First Coloplast Test product 2.; Treatment sequence 1; First Coloplast Test product 1; Treatment sequence 3, First Coloplast SenSura

Coloplast Test Product 2 DEVICE

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

Treatment seqence 2; First Coloplast Test product 2.; Treatment sequence 1; First Coloplast Test product 1; Treatment sequence 3, First Coloplast SenSura

Coloplast SenSura DEVICE

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Also known as: SenSura 1-piece

Treatment seqence 2; First Coloplast Test product 2.; Treatment sequence 1; First Coloplast Test product 1; Treatment sequence 3, First Coloplast SenSura

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 (mandatory in DK)
• Be at least 18 years of age and have full legal capacity.
• Be able to handle the products themselves
• Have an ileostomy with a diameter between 10 and 40 mm.
• Have had their ostomy for at least three months.
• Have within the last month used a 1-piece flat product with open bag
• Currently using midi or maxi bags
• Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.
• Be suitable for participation in the investigation
• Must be able to use custom cut product
• Negative result of a pregnancy test for women of childbearing age (only DK)

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 systemic steroid or local treatment in the peristomal area
• Are pregnant or breastfeeding
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Has participated in the previous explorative Coloplast studies CP236 and CP237
• Are currently or during the study using ostomy belt
• Has a stoma below skin surface
• Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)
• Has known hypersensitivity towards any of the test products

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (4)

Holtedam 3

Humlebæk, 3050, Denmark

Location

QPS Nederlands

Groningen, 9713, Netherlands

Location

Sykepleierklinikken

Larvik, 3269, Norway

Location

Synexus Limited

Chorley, Lancashire, PR71NY, United Kingdom

Location

Results Point of Contact

• Title: Medical Director
• Organization: Coloplast

dkbir@coloplast.com

+45 4911 1395

Study Officials

• Birte P 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: August 6, 2013
• First Posted: October 8, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 10, 2020
• Results First Posted: September 17, 2014

Record last verified: 2020-08

Locations

NL (1); GB (1); DK (1); NO (1)