Assessment of New Ostomy Devices in Subjects Having an Ileostomy

NCT03427203 | Completed

• 1 other identifier: CP264
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 3

Brief Summary

The study investigates the performance of three new adhesives with regard to leakage and the skin condition.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Trans epidermal water loss

  Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage

  14 days

Study Arms (2)

Arm 1

EXPERIMENTAL

The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3

Device: SenSura Mio; Device: Coloplast Ostomy device 1; Device: Coloplast Ostomy device; Device: Coloplast Ostomy device 3

Arm 2

EXPERIMENTAL

The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2

Device: SenSura Mio; Device: Coloplast Ostomy device 1; Device: Coloplast Ostomy device; Device: Coloplast Ostomy device 3

Interventions

SenSura Mio DEVICE

SenSura Mio is a marked ostomy device which is used as the comparator in this study

Arm 1; Arm 2

Coloplast Ostomy device 1 DEVICE

Coloplast Ostomy device 1 a newly developed ostomy device

Arm 1; Arm 2

Coloplast Ostomy device DEVICE

Coloplast Ostomy device 2 a newly developed ostomy device

Arm 1; Arm 2

Coloplast Ostomy device 3 DEVICE

Coloplast Ostomy device 3 a newly developed ostomy device

Arm 1; Arm 2

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 for at least 3 months
• Must be able to use custom cut product
• Can use a product with max cut size 45 mm
• Self-reported problems with leakage (3 x within 14 days)
• Get a negative result of a pregnancy test for women of childbearing age (only DK)

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, e.g. below 15 mg methotrexate for rheumatoid arthritis)
• Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
• Are pregnant or breastfeeding
• Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
• Have known hypersensitivity towards any of the products used in the investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (3)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

CCBR Vejle

Vejle, 7100, Denmark

Location

QPS Netherlands

Groningen, 9713, Netherlands

Location

Study Officials

• Birte P Jakobsen, MD

  Medical Director

  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: January 29, 2018
• First Posted: February 9, 2018
• Study Start: January 9, 2018
• Primary Completion: April 6, 2018
• Study Completion: April 6, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

NL (1); DK (2)