Performance Study of Newly Developed Ostomy Products

Phase 4

Completed

• Conditions: Stoma Colostomy
• Interventions: Device: SenSura Mio; Device: Standard Care

• Registration Number: NCT01513330
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-16
• Study First Posted: 2012-01-20
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Results First Submitted: 2013-08-06
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-21
• Last Update Submitted: 2013-11-21
• Results First Posted: 2014-01-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Standard Care, then SenSura Mio	SenSura Mio	Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio
First Standard Care, then SenSura Mio	Standard Care	Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio
First SenSura Mio, then Standard Care	SenSura Mio	Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
First SenSura Mio, then Standard Care	Standard Care	Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)

Primary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (1)

Publicare; 🇩🇪 Cologne, Køln, Germany