A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

Ileostomy - Stoma Clinical Trial

Official title:

A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154944
• Other study ID #: CP275
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: June 2018
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority

2. Be at least 18 years of age and have full legal capacity

3. Have had their ileostomy for at least 3 months

4. Have an ileostomy with a diameter between 10 and 55 mm

5. Be able to handle the Clinical App. and product themselves

6. Must be able to use custom cut product

7. Minimum change of product every second day

8. If current product is SenSura Mio - Be willing to use Maxi bag during investigation

9. Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study.

10. Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. 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)

2. 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.

3. Are pregnant or breastfeeding**

4. Are participating in other interventional clinical investigations or have previously participated in this investigation

5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)

6. Have known hypersensitivity towards any of the products used in the investigation

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Ostomy device 1
This device consists of a known adhesive and a new top film
• Ostomy device 2
This device consists of a new adhesive and a known top film
• Ostomy device 3
This device consists of a known adhesive and a new top film

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebaek

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trans epidermal water loss	The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.	7 days