Performance Study of Newly Developed Ostomy Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01513330
First received: January 10, 2012
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Stoma Colostomy
Device: SenSura Mio
Device: Standard Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 122
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Standard Care, then SenSura Mio
Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio
Device: SenSura Mio
Ostomy product - 1 piece closed bag
Device: Standard Care
Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
Experimental: First SenSura Mio, then Standard Care
Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
Device: SenSura Mio
Ostomy product - 1 piece closed bag
Device: Standard Care
Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513330

Locations
Germany
Publicare
Cologne, Køln, Germany
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Wenche Sundberg, stoma nurse Diakonhjemmet Sykhus, Oslo
Principal Investigator: Merete Bjørke, Stoma Nurse St. Olavs Hopsital
Principal Investigator: Vigids Dagsland, Stoma Nurse Haugesund Sykhus
Principal Investigator: Randi Melum, Stoma Nurse St. Olavs Hospital
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01513330     History of Changes
Other Study ID Numbers: CP219
Study First Received: January 10, 2012
Results First Received: August 6, 2013
Last Updated: November 21, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on April 17, 2014