Performance Study of Newly Developed Ostomy Products

Stoma Colostomy Clinical Trial

Official title:

An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513330
• Other study ID #: CP219
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2012
• Last updated: November 21, 2013
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2013
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written informed consent.

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

3. Have experienced leakage under the base plate at least once a week over the last two weeks.

4. Be able to handle the bags themselves or with help from caregiver (e.g. spouse).

5. Have a colostomy with a diameter between 20 and 45 mm.

6. Have had their ostomy for at least three months.

7. Currently use a 1-piece flat product with closed bag.

8. Use minimum 1 product per day.

9. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).

2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.

3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.

4. Are pregnant or breastfeeding.

5. Participating in other interventional clinical investigations or have previously participated in this investigation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stoma Colostomy

Intervention

Device:
• SenSura Mio
Ostomy product - 1 piece closed bag
• Standard Care
Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.

Locations

Country	Name	City	State
Germany	Publicare	Cologne	Køln

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)	Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.	14 days	Yes