Performance Study of Newly Developed Ostomy Products

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stoma Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Publicare

Cologne, Køln, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have given written informed consent.
Be at least 18 years of age and have full legal capacity.
Have experienced leakage under the base plate at least once a week over the last two weeks.
Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
Have a colostomy with a diameter between 20 and 45 mm.
Have had their ostomy for at least three months.
Currently use a 1-piece flat product with closed bag.
Use minimum 1 product per day.
Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).

Exclusion criteria

Use irrigation during the study (flush the stoma with water).
Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
Are pregnant or breastfeeding.
Participating in other interventional clinical investigations or have previously participated in this investigation.

Treatment and study plan

SenSura Mio

Device

Ostomy product - 1 piece closed bag

Standard Care

Device

Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.

Primary outcomes

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)

Time frame: 14 days

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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jan 20, 2012
Registry last updated: Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed