Phase 4
N=122
Performance Study of Newly Developed Ostomy Products
Stoma Colostomy
Bottom Line
View on ClinicalTrials.gov: NCT01513330 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: 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) — 3.8; 3.4 points on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SenSura Mio (Device); Standard Care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
3.8; 3.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01513330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.