Phase 3
N=54
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
Colostomy
Bottom Line
View on ClinicalTrials.gov: NCT01243294 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Leakage (Percent of All Base Plates With Leakage) — 27; 30 Percent of Base plates
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SS (Device); SenSura (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leakage (Percent of All Base Plates With Leakage) |
27; 30 | — |
| SECONDARY Adverse Events |
1; 2 | — |
| SECONDARY Security (Subjects Own Assessment) |
48; 28 | — |
| SECONDARY Handling at Appliance (Subjects Own Assessment) |
89; 91 | — |
| SECONDARY Comfort (Subjects Own Assessment) |
93; 67 | — |
| SECONDARY Wear Time (Registered by Subject When Applying and Removing a Product) |
11.46; 11.41 | — |
Summary
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Be able to handle the bags themselves (application, removal)
- Have a colostomy with a diameter less than 45 mm
- Have had a colostomy for at least 3 months
- Currently use a 1-piece flat ostomy appliance with closed bag
- is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
- Use minimum 1 product per day
- Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
- Have the mental capacity to understand the study and questionnaires
Exclusion Criteria
- Use irrigation during the study (flush the stoma with water).
- Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
- Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
- Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
- Are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01243294). 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.