Performance Study of Newly Developed Ostomy Products

• ClinicalTrials.gov Identifier: NCT01513330
• Recruitment Status: Completed
• First Posted: January 20, 2012
• Results First Posted: January 9, 2014
• Last Update Posted: January 9, 2014
• Sponsor: Coloplast A/S
• Information provided by (Responsible Party): Coloplast A/S

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Stoma Colostomy	Device: SenSura Mio; Device: Standard Care	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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.
• Study Start Date: November 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT01513330
• Other Study ID Numbers: CP219
• First Posted: January 20, 2012
• Results First Posted: January 9, 2014
• Last Update Posted: January 9, 2014
• Last Verified: November 2013